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 .
In view of the appeal brief filed on 10/02/2025, PROSECUTION IS HEREBY REOPENED. New grounds of rejections are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619
The application is examined in view of the mixture of 6-O-a-D-glucopyranosyl-D- mannitol dihydrate with 6-O-a-D-glucopyranosyl-D-sorbitol (isomalt) as specific isomaltulose derivative, and a mixture of ethylene glycol and vinyl alcohol graft copolymer with polyvinyl alcohol as specific adherent polymers. Claims 1-3, 5-12, 16-21 and 23-25 read on the elected species and are under examination.
Claims 1-3, 5-12, 16-25 are pending, claims 1-3, 5-12, 16-21 and 23-25 are under examination.
Claim Objections
Claim 21 is objected for reciting a typo “polaxmer” which should be “Poloxamer”. Proper correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 17 is 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. Claim 17 recites 70% of water and fails to include all the limitations of the claim 1 upon which it depends because claim 1 requires solids content 35% which indicating less than 65% of water. 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 § 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-3, 5-12, 16-21 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Kolter et al. (US20050107498) as evidenced by Farrell et al. (US20100291159) and Maschke et al. (US20130084338).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Kolter et al. teaches A quick dissolving film coating composition for coating solid substrates is composed of a) 10-90% by weight of a polyvinyl alcohol-polyether graft copolymer (component A), b) 5-80% by weight of at least one further component containing at least one functional group selected from the group consisting of hydroxyl, amide and ester functions (component B), and c) 0-70% by weight of further customary coating constituents (components C) (abstract; claim 1). Component B is polyvinyl alcohol, polyethylene glycol, polyethylene glycol-propylene glycol copolymers, isomalt or hydroxypropylmethylcellulose (claims 5-9). The Substrate is selected from pharmaceutical, cosmetic, and agrochemical product forms, Seed, dietary Supplements, and foods (claim 26). The components C comprise dyes, lakes, pigments, detackifiers, fillers, Shine enhancers, wetting agents, Surfactants, foam preventatives, protective colloids, buffer Substances, pH regulators, and plasticizers (claim 20). The components include titanium, Talc, pigment, surfactant such as sodium lauryl sulfate (page 3, [0072-0084]); and the combinations according to the invention produce unenvisaged and surprising product properties and film properties. Where, for example, the polyvinyl alcohol-polyether graft copolymers (PVA-PEG graft copolymer) of the invention are combined with polyvinyl alcohols, synergistic effects are found in as much as at certain proportions the elongation at break, which characterizes the flexibility of the films, is higher than that of the individual components (page 3, [0084-0085]). PVA-PEG graft copolymer is the same as claimed ethylene glycol and vinyl alcohol graft copolymer, as evidenced by Farrell et al graft copolymers polyvinyl alcohol and polyethylene glycol (PEG) such as the PVA-PEG graft copolymer is sold under the trade name Kollicoat IR ([0017]) and Kollicoat IR is also referred to as a graft polymer polyethylene glycol-polyvinyl alcohol as evidenced by Maschke et al, see page 6, [0127]. The coating composition is made by spraying of all components in water (claims 21-26). The spraying suspension solids content up to 50% can be applied (page 4, [0090]) and in one example, the solids content is 35% with low viscosity and the spraying formulation is homogenous (page 7, [0132]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Kolter et al. is that Kolter et al. do not expressly teach all claimed ingredients in one embodiment.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce the instant invention.
Since Kolter et al. teaches at least one Component B which is polyvinyl alcohol, polyethylene glycol, polyethylene glycol-propylene glycol copolymers, isomalt or hydroxypropylmethylcellulose, it is obvious to have the mixture of polyvinyl alcohol, polyethylene glycol, isomalt and hydroxypropylmethylcellulose as component B.
Regarding claims 1-3 and 21, Kolter et al. teaches a film coating composition with 35-50% of solids content with low viscosity for drug and supplement comprising 10-90% by weight of a polyvinyl alcohol-polyether graft copolymer (PVA-PEG graft copolymer; component A); 5-80% of polyvinyl alcohol, polyethylene glycol, isomalt and hydroxypropylmethylcellulose (component B) and 0-70% of titanium dioxide, Talc, pigment and sodium lauryl sulfate (component C). While Kolter et al. does teach spraying the film coating composition and having low viscosity, Kolter et al is silent about specific low viscosity less than 500cp, however, since Kolter et al. teaches the same or substantially same film composition with low viscosity for spraying, this same or substantially same film composition will necessarily have the same low viscosity less than 500cp. MPEP 2112, Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product.
Regarding the limitation of ethylene glycol and vinyl alcohol graft copolymer, Kolter et al. teaches polyvinyl alcohol-polyether graft copolymer (PVA-PEG graft copolymer), as evidenced by Farrell et al. and Maschke graft copolymers polyvinyl alcohol and polyethylene glycol (PEG) such as the PVA-PEG or PEG-PVA is the same graft copolymer sold under the trade name Kollicoat IR.
Regarding claims 5-6, Kolter et al. teaches 10-90% by weight of a polyvinyl alcohol-polyether graft copolymer and 5-80% of polyvinyl alcohol, the amount of mixture would be from 15-95%.
Regarding claims 7-8, prior arts teach 0-70% of titanium dioxide, Talc, pigment and sodium lauryl sulfate.
Regarding claims 9-12, 20 as well as resists dissolution properties in claim 21, they are considered as inherent properties of prior art composition. Since Kolter et al. teaches the same or substantially same composition, this same or substantially same composition will necessarily have the same properties. MPEP 2112, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Regarding claims 16 and 18, they are intended use of film composition for the preparation of a dispersion instead of film composition itself, thus, not limiting. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claims 19 and 23-25, these are product by process, please note that in product-by-process claims, “once a product appearing to be substantially identical is found and a 35 U.S.C. 102/103 rejection [is] made, the burden shifts to the applicant to show an unobvious difference.” MPEP 2113. This rejection under 35 U.S.C. 102/103 is proper because the “patentability of a product does not depend on its method of production.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicants’ hydrated (vitrified matrix) collagen gel differs and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Regarding the amount of ingredients in claim 17 and 19, after excluding water, Kolter et al. teaches claimed range for all ingredients except ethylene glycol-vinyl alcohol graft copolymer mixed with polyvinyl alcohol, and one of ordinary skill in the art would have been motivated to optimize the amount and have the claimed range, in the absence of showing criticality of claimed arrange.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1-3, 5-12, 16-21 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Kolter et al. (US20050107498) in view of Grillo et al. (US6348090) as evidenced by Farrell et al. (US20100291159) and Maschke et al. (US20130084338).
In arguendo that viscosity less than 500cp is not inherent property of Kolter et al. composition, it is still obvious according to the following discussion.
Determination of the scope and content of the prior art
(MPEP 2141.01)
Kolter et al., as evidenced by Farrell et al. and Maschke et al. teachings have already been discussed in the above 103 rejection and are incorporated herein by reference.
Grillo et al. teaches A dry film coating composition for forming a coating suspension for film coating nutritional supplements, pharmaceutical tablets, and the like, including tapica dextrin and a detackifie (abstract). The inventive aqueous coating solution/suspension/dispersion has a viscosity that is markedly lower than the viscosities of coating suspensions based on hydroxypropyl methylcellulose, and maltodextrin. For example, the viscosity of the formulation of Example 1 at a 30% solids level is 18.5 cP, at 40% solids is 87.5 cP, and at 50% solids is 381 cP. Accordingly, the tablet weight gain due to coating may be reduced to 0.5% to 0.75%, which is substantially lower than the tablet weight gain associated with prior art coating systems, and still obtain a coated tablet having an excellent gloss. Also, due to the lower viscosity of the coating solutions/suspensions/dispersions of the invention, there is less of a likelihood of clogging of spraying equipment during the coating process, and the ability to use higher solids content in the inventive coating suspension than that may be advisable to use in the prior art systems (column 18, line 12-27).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Kolter et al., is that Kolter et al., do not expressly teach viscosity less than 500cp. This deficiency in Kolter et al. is cured by the teachings of Grillo et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kolter et al., as suggested by Grillo et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to have viscosity of the film coating composition for spray less than 500cp because this is optimization under prior art condition or through routing experimentation. MPEP 2144.05. Under guidance from Grillo et al. teaching film coating composition with solid content 30-50% having low viscosity such as 381cp for less likelihood of clogging of spraying equipment during the coating process, since it is advantage to have low viscosity to avoid clogging of spraying equipment during the coating process, it is obvious for one of ordinary skill in the art to viscosity of the film coating composition for spray less than 500cp and produce instant claimed invention with reasonable expectation of success.
Since Kolter et al. teaches at least one Component B which is polyvinyl alcohol, polyethylene glycol, polyethylene glycol-propylene glycol copolymers, isomalt or hydroxypropylmethylcellulose, it is obvious to have the mixture of polyvinyl alcohol, polyethylene glycol, isomalt and hydroxypropylmethylcellulose as component B.
Regarding claims 1-3 and 21, prior art teaches a film coating composition with low viscosity less than 500cp with 35-50% of solids content for drug and supplement comprising 10-90% by weight of a polyvinyl alcohol-polyether graft copolymer (PVA-PEG graft copolymer; component A); 5-80% of polyvinyl alcohol, polyethylene glycol, isomalt and hydroxypropylmethylcellulose (component B) and 0-70% of titanium dioxide, Talc, pigment and sodium lauryl sulfate (component C).
Regarding the limitation of ethylene glycol and vinyl alcohol graft copolymer, Kolter et al. teaches polyvinyl alcohol-polyether graft copolymer (PVA-PEG graft copolymer), as evidenced by Farrell et al. and Maschke graft copolymers polyvinyl alcohol and polyethylene glycol (PEG) such as the PVA-PEG or PEG-PVA is the same graft copolymer sold under the trade name Kollicoat IR.
Regarding claims 5-6, Kolter et al. teaches 10-90% by weight of a polyvinyl alcohol-polyether graft copolymer and 5-80% of polyvinyl alcohol, the amount of mixture would be from 15-95%.
Regarding claims 7-8, prior arts teach 0-70% of titanium dioxide, Talc, pigment and sodium lauryl sulfate.
Regarding claims 9-12, 20 as well as resists dissolution properties in claim 21, they are considered as inherent properties of prior art composition. Since prior art teaches the same or substantially same composition, this same or substantially soma composition is expected to have the same properties. MPEP 2112, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Regarding claims 16 and 18, they are intended use of film composition for the preparation of a dispersion instead of film composition itself, thus, not limiting. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claims 19 and 23-25, these are product by process, not limiting. With respect to the USC 102/103 rejection above, please note that in product-by-process claims, “once a product appearing to be substantially identical is found and a 35 U.S.C. 102/103 rejection [is] made, the burden shifts to the applicant to show an unobvious difference.” MPEP 2113. This rejection under 35 U.S.C. 102/103 is proper because the “patentability of a product does not depend on its method of production.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicants’ hydrated (vitrified matrix) collagen gel differs and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Regarding the amount of ingredients in claim 17 and 19, after excluding water, Kolter et al. teaches claimed range for all ingredients except ethylene glycol-vinyl alcohol graft copolymer mixed with polyvinyl alcohol, and one of ordinary skill in the art would have been motivated to optimize the amount and have the claimed range, in the absence of showing criticality of claimed arrange.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Argument:
Applicants argued one of ordinary skill in the art would not have arrived at the claimed viscosity based on the Kolter et al. All related arguments are incorporated herein by reference.
In response to this argument: this is not persuasive. As discussed in the above 103 rejections, Since Kolter et al. teaches at least one Component B which is polyvinyl alcohol, polyethylene glycol, polyethylene glycol-propylene glycol copolymers, isomalt or hydroxypropylmethylcellulose, it is obvious to have the mixture of polyvinyl alcohol, polyethylene glycol, isomalt and hydroxypropylmethylcellulose as component B. Regarding the arguments that there is no working example comprising isomalt. It is well settled, however, that the teachings of a reference are not limited to the working examples. See in re Miiis and Pairner, 470 F.2d 649 (CCPA 1972) ("[A] reference is not limited to the disclosure of specific working examples."), In re Chapman and Cosby, 357 F.2d 418, (CCPA 1966) ("A reference can be used for all it realistically teaches, and is not limited to the disclosures in its specific illustrative examples."), and In re Widmer, Batzer and Nikles, 353 F2d 752 (CCPA 1965) ("Examples in a reference are merely that, exemplary of the broader disclosure, all of which is available for what it clearly teaches."). As discuused in the above 103 rejection, the claimed viscosity less than 500cp is inherent property of composition of Kolter et al. In arguendo that viscosity less than 500cp is not inherent property of Kolter et al. composition, it is still obvious under guidance from Grillo et al. teaching film coating composition with solid content 30-50% having low viscosity such as 381cp for less likelihood of clogging of spraying equipment during the coating process, since it is advantage to have low viscosity to avoid clogging of spraying equipment during the coating process, it is obvious for one of ordinary skill in the art to viscosity of the film coating composition for spray less than 500cp and produce instant claimed invention with reasonable expectation of success. Therefore, the 103 rejection is still proper.
Applicants argue unexpected results from example 18 of specification.
In response to this argument: this is not persuasive. The example 18 of specification appears a composition with different combination of polymer, and not a film coating dispersion which may comprise additional solid ingredients such as titanium dioxide, Talc, pigment. MPEP 716.02(b), Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). Thus, those results in example 18 are not sufficient to overcome the 103 rejection at least for the following reasons. Firstly, applicants failed to compare with closest prior art condition. Secondly, the results are not in commensurate with the scope of claimed invention. Thus, the 103 rejection is still proper.
Applicants argued that Maschke et al. does not teach the viscosity of film coating composition.
In response to this argument: this is not persuasive. Maschke et al. is not relied on for teaching viscosity in the modified 103 rejections, and this argument is moot.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after weighing all the evidence, the Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts which is more convincing than the evidence which has been offered in opposition to it.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JIANFENG SONG/Primary Examiner, Art Unit 1613
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619