Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Detailed Action
This application is a continuation of US application 18/376978, now abandoned, filed October 5, 2023, which is a continuation of US application 17/480571, now abandoned, filed September 21, 2021, which is a continuation of US application 16/773164, now US patent 11130823, filed January 27, 2020, which is a continuation of US application 15/139896, now US patent 10544233, filed April 27, 2016, which is a divisional application of US application 13/491197, now US patent 9353191, filed June 7, 2012, which claims benefit of provisional applications 61/542494, filed October 3, 2011, and 61/494298, filed June 7, 2011. Claims 1-20 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted January 6, 2025, is acknowledged wherein claims 9 and 10 are amended and claims 21 and 22 are canceled.
Information Disclosure Statement
The information disclosure statement filed January 6, 2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the foreign patent documents and non-patent literature documents listed therein have only been considered to the extent that legible copies could be located in the files of this application and all parent applications in this patent family. All other citation are struck through and not considered.
Drawings
The drawings are objected to because they are of sufficiently low resolution to make interpretation difficult. Specifically, text appearing in figures 4 and 9-12 is illegible due to low resolution. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 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. Claim 3 recited the range “4% or greater 8% by weight.” It is unclear what actual range is meant by this range, which could reasonably be interpreted as either “4% or greater but less than 8%,” or “from 4% to greater than 8%.” Therefore this claim is indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim6 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. This claim depends from claim 3, which as described above is indefinite. However, if claim 3 is interpreted as reciting a range of 4-8%, the sole additional limitation introduced by claim 6 is a restatement of the same concentration range of 4-8% recited in the parent claim 3, thereby failing to further limit claim 3. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections – 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1, 3, 6, 10, 11, and 14 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Sannino et al. (PCT international publication WO2010/059725, reference cited in PTO-1449)
Independent claim 1 is directed to a process for producing a polymer hydrogel comprising steps (a)-(d) of preparing an aqueous solution of a water soluble polysaccharide and a polycarboxylic acid, agitating, isolating a composite form the solution, and heating the composite resulting in crosslinking. Dependent claims 3 and 6 further define the concentrations of the components. Dependent claims 10, 11, 14, and 15 define the polysaccharide as carboxymethylcellulose and the polycarboxylic acid as citric acid.
Sannino et al. discloses an edible polymer hydrogel that swells in the stomach and small intestine to enhance satiety. (p. 8 lines 5-7) Preferred polymers include cellulose derivatives, preferably carboxymethylcellulose. (p. 27 line 31 – p. 28 line 10) The polymer is crosslinked with a crosslinker preferably including citric acid or malic acid. (p. 28 lines 10-11) In one embodiment the crosslinked polymer is made by a process involving removing water from the reaction mixture and maintaining the dry mixture at elevated temperature to continue the reaction. (p. 34 lines 16-25) In another preferred embodiment the polymers to be crosslinked include an ionic polymer such as carboxymethylcellulose and a non-ionic polymer such as hydroxyethylcellulose, in a weight ratio of 3:1. (p. 39 lines 21-26) In a preferred embodiment the total amount of carboxymethylcellulose is 2-10%, the total amount of citric acid is about 0.01-5%. (p. 40 lines 3-10)
In one specific embodiment (p. 44 lines 17-34) a concentration of 2% of a 3:1 NaCMC/HEC mixture is mixed with between 1.75-20% citric acid based on the weight of the polymer, under continual stirring, which is considered to be agitation as recited in present claim 1, then dried before being heated at 80OC to carry out the crosslinking reaction. In another example the citric acid is present at 0.5% of the weight of CMCNa, or the polysaccharides are present at a concentration of 4% of the total weight of the solution. (p. 54 lines 1-13) Therefore these examples anticipate the claimed invention.
Claims 1, 3-5, 9, and 10 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Omura. (JP2008-285611, reference cited in PTO-1449)
Independent claim 1 is directed to a process for producing a polymer hydrogel comprising steps (a)-(d) of preparing an aqueous solution of a water soluble polysaccharide and a polycarboxylic acid, agitating, isolating a composite form the solution, and heating the composite resulting in crosslinking. Dependent claims 3-5 and 9 further define the concentrations of the components. Dependent claim 10 defines the polysaccharide as carboxymethylcellulose.
Omura discloses a carboxyalkyl cellulose salt which is crosslinked. (paragraph 12) In one example (paragraphs 66-68) this product is made by a process involving dissolving 200g of sodium carboxymethylcellulose in 800mg of water, along with 0.5g of tartaric acid, or 0.25% of the NaCMC. This mixture is then kneaded to from a rice cake shape, which is reasonably considered to comprise agitation, then dried at 140C and crosslinked. This example is seen to anticipate the claimed invention.
Claims 1, 2, 4, 5, 9-11, and 16 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Qin. (PCT international publication WO01/87365, reference cited in PTO-1449)
Independent claim 1 is directed to a process for producing a polymer hydrogel comprising steps (a)-(d) of preparing an aqueous solution of a water soluble polysaccharide and a polycarboxylic acid, agitating, isolating a composite form the solution, and heating the composite resulting in crosslinking. Dependent claim 2 further requires the presence of a granulation step somewhere prior to step (d). Dependent claims 4, 5, and 9 further define the concentrations of the components. Dependent claims 10 and 11define the polysaccharide as carboxymethylcellulose and the polycarboxylic acid as citric acid.
Qin discloses water-swellable modified polysaccharides. (p. 5 second paragraph) In one example (Example I, pp. 34-35, and samples 3-7 in table 1 paragraph 36) a method is carried out wherein sodium carboxymethylcellulose is dissolved in solution with 0.3% of the polycarboxylic crosslinking agent chitosan glutamate. The example describes the two solutions as being “thoroughly mixed,” which his reasonably considered to comprise agitating the solutions. This mixture is then dried, ground into granules in a blender, and heated to achieve cross-linking. In another embodiment (example IX on p. 58 and table 20 on p. 61) the crosslinking agent is citric acid at a ratio of for example 0.3% of the total weight of carboxymethylcellulose) Therefore these examples anticipate the claimed invention.
Claim Rejections – 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 4, 5, 7-9, 12, 13, and 15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sannino et al. (PCT international publication WO2010/059725, reference cited in PTO-1449)
The disclosure of Sannino et al. is discussed above. Sannino et al. does not specifically disclose embodiments wherein the concentration of polysaccharide is 6% and the concentration of citrate is 0.3% of the concentration of polymer.
However, it would have been obvious to one of ordinary skill in the art at the time of the invention to produce the products described by Sannino et al. using a concentration of 6% of the polysaccharide and a concentration of citric acid which is 0.3% of the weight of the polysaccharide, or 0.018%. One of ordinary skill in the art would have been motivated to do so and would have reasonably expected success because these values are within the ranges described by Sannino et al. (2-10% polysaccharide and 0.01-5% citrate) as being embodiments of the disclosed invention.
Therefore the invention taken as a whole is prima facie obvious.
Claims 2 and 16-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sannino et al. as applied to claims 1 and 3-15 above, and further in view of Qin. (PCT international publication WO01/87365, Reference cited in PTO-1449)
The disclosure of Sannino et al. is discussed above. Sannino et al. does not specifically disclose an embodiment wherein there is a step of granulating the composition before heat-treating it to bring about crosslinking.
The disclosure of Qin is discussed above.
It would have been obvious to one of ordinary skill in the art at the time of the invention to carry out the synthesis methods described by Sannino et al. using an additional step of grinding the solid material in a blender before cross-linking it in an oven. One of ordinary skill in the art would have been motivated to add this step and would have reasonably expected success in doing so because Qin discloses that it is useful in carrying out a similar method of producing a similar product.
Therefore the invention taken as a whole is prima facie 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 §§ 706.02(l)(1) – 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-13 and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 9855294. (Cited in PTO-892, herein referred to as ‘294) Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘294 anticipate or render obvious t the claimed invention.
Specifically, claim 12 of ‘294 describes using a material which was produced by a method comprising providing a solution of sodium carboxymethylcellulose and citric acid having concentrations of these two components which fall within the claimed amounts, drying the solution, grinding the solid residue into particles, and heating the ground particles to bring about crosslinking. This process differs from the claimed invention in that it does not specifically describe steps of preparing and agitating the NaCMC/citrate solution. However, one of ordinary skill in the art would be motivated by the directions to provide such a solution to look to the specification of ‘294 for guidance on how to carry out this step. Example 1 in column 12 of ‘294 describes mixing the components in water using a low shear mixing vessel. This process would involve preparing a solution and then agitating it as recited in the claims, and it would be obvious to one of ordinary skill in the art to carry out the process of providing a solution using these steps for guidance. With respect to the specific concentrations of NaCMC and citrate recited in instant claims 8 and 13, for example, one of ordinary skill in the art would have found it to be obvious to optimize the amount of ingredients within the broader ranges recited in the claims of ‘294.
Claims 1-13 and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-14 of US patent 10098907 (cited in PTO-1449, herein referred to as ‘907). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘907 anticipate the claimed invention.
Specifically, claims 14-18 of ‘907 describe using a material which was produced by a method comprising preparing a solution of sodium carboxymethylcellulose and citric acid having concentrations of these two components which fall within the claimed amounts, agitating the solution, drying the solution, grinding the solid residue into particles, and heating the ground particles to bring about crosslinking. With respect to the specific concentrations of NaCMC and citrate recited in present claims 8 and 13, for example, one of ordinary skill in the art would have found it to be obvious to optimize the amount of ingredients within the broader ranges recited in the claims of ‘907.
Claims 1-13 and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-17 of US patent 10179824 (cited in PTO-1449, herein referred to as ‘824). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘824 anticipate or render obvious the claimed invention.
Specifically, claims 13-19 of ‘824 describe a method comprising preparing a solution of sodium carboxymethylcellulose and citric acid having concentrations of these two components which fall within the claimed amounts, agitating the solution, drying the solution, grinding the solid residue into particles, and heating the ground particles to bring about crosslinking. With respect to the specific concentrations of NaCMC and citrate recited in instant claims 8 and 13, for example, one of ordinary skill in the art would have found it to be obvious to optimize the amount of ingredients within the broader ranges recited in the claims of ‘626. Regarding present claim 20, claim 16 of ‘824 describes a step of washing the crosslinked NaCMC with water.
Claims 1-13 and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10544233. (Cited in PTO-1449, herein referred to as ‘233) Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘233 anticipate the present claims.
In particular, claim 1 of ‘233 claims a method for making a crosslinked polymer hydrogel which comprises steps of preparing an aqueous solution of CMC and citric acid, agitating the solution, isolating a CMC/citric acid composite, granulating the composite to produce composite particles, heating the particles to a temperature of at least 80OC, washing the crosslinked polymer, drying, and granulating the polymer hydrogel to produce particles. This process includes all of the steps recited in present claim 1, thereby anticipating said claim, as well as anticipating claims 10 and 11 which claim the specific polymer CMC and polyacid citric acid, and claims 2, 16, 17, and 20 including granulating or grinding steps. Furthermore the concentrations of 4-8% for the CMC and 0.15-0.3% for citric acid anticipate the ranges in present claims 3, 6, and 18. Regarding the narrower concentration ranges recited in present claims 4, 5, 7-9, and 19, these ranges are specifically recited in dependent claims 2-5 of ‘233.
Claims 1-13 and 16-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 11628184 (Cited in PTO-892, herein referred to as ‘184) in view of Sannino et al. (PCT international publication WO2010/059725, reference cited in PTO-1449)
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 11 of ‘184 describes a process for making a crosslinked carboxymethylcellulose comprising steps of providing a solution of CMC and citric acid in water, evaporating the water, grinding the residue to form particles, and heating the particles at a temperature of over 80OC to crosslink the CMC. While this process does not disclose an agitation step, as discussed in the disclosure of Sannino et al. WO2010/059725 under 35 USC 102, especially example 1 on p. 44, the use of stirring to prepare a solution of CMC and citric acid for a similar process is described, thereby suggesting to one of ordinary skill in the art that it is useful to agitate such a solution by stirring to ensure complete dissolution, thereby rendering obvious present claim 1 as well as dependent claims 2, 10, 11, 16, and 17.
Furthermore the specific concentration ranges recited in claim 11 of ‘184 infringe the ranges recited in present claims 3, 6, and 7. Still further these ranges substantially overlap the ranges recited in present claims 4, 5, 8, 9, 18, and 19, rendering said ranges obvious to one of ordinary skill in the art.
Claims 1-13 and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-9 of U.S. Patent No. 10584183. (Cited in PTO-1449, herein referred to as ‘183) Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘183 anticipate the present claims.
In particular, claim 7 of ‘183 claims a crosslinked polymer hydrogel which is made by a method comprising steps of preparing an aqueous solution of CMC and citric acid, agitating the solution, isolating a CMC/citric acid composite, granulating the composite to produce composite particles, heating the particles to a temperature of at least 80OC, washing the crosslinked polymer, drying, and granulating the polymer hydrogel to produce particles. This process includes all of the steps recited in present claim 1, thereby anticipating said claim, as well as anticipating claims 10 and 11 which claim the specific polymer CMC and polyacid citric acid, and claims 2, 16, 17, and 20 including granulating or grinding steps. Furthermore the concentrations of 4-8% or 6% for the CMC and 0.15-0.3% or 0.2% for citric acid recited in dependent claims 8 and 9 anticipate the ranges in present claims 3-9, 13, and 17-19.
Conclusion
No claims are allowed in this action.
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/ANDREA OLSON/Primary Examiner, Art Unit 1693 8/27/2026
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