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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/16/2026 has been entered.
Status of the Application
Claims 22-25, 36-39, 42, 44-46, 48, 59, 62, 65-69 are pending.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 22-25, 36-39, 42, 44-46, 48, 59, 62, 65-69 are rejected under 35 U.S.C. 103 as being unpatentable over Baker (US 2012/0329751 A1) and Pharmaceutical Solutions for Oral Administration (Chapter 1, pages 1-24; 2008) (hereby referred as Pharmaceutical) in combination.
Determining the scope and contents of the prior art
Baker discloses same chitosan derivatives with same molecular weight, n value (20-6000) and % of acetyl (at least 1%), arginine (at least 2%, 4-30%) (30% reads on limitation between 15-40%; 18% to about 40% of the instant claims and limitation of at least 18%) and H (at least 25%) as R1, molecular weight (20kDa-40kDa etc.), polydispersity index (1.0-2.5) as in the instant claims and using such compounds in a composition as solid, liquid, semisolid, capsule, gel, food etc. in disrupting (reducing, dissolving etc.) a biofilm in the gut of the subject from unbalanced population of bacteria by reducing pathogenic bacteria (not harming useful bacteria, i.e. maintaining beneficial or diversity of commensal microflora in the gut), for example C. difficile etc. such as in GI tract with examples of such treatment (abstract, 0003-0017; 0025-0041, 0046, 0047, 0090-0095, 0100, 0133, 0191, 0617-0618, 1285, 2024-2037, 2042-2043, 2050-2065, 2113, 2115, 2116, 2024-2037, 2141-2147):
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(same as definition of dysbiosis as described by the instant specification paragraphs 0004-0006, 0049, 0051, 0052, 0053, 0054, 0059-0060; for example C. difficile etc.; see paragraph 0005).
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In fact, both the cited prior art and the instant specification teaches treating, same infections caused by same bacteria. The cited prior art discloses that the composition may be useful in disrupting (reducing, dissolving etc.) a biofilm resulted from an allergic reaction, inflammation, GI tract infection etc. and may be administered in combination with other agents (paragraphs 2033-2037; 2048-2065). The cited prior art discloses administration of such composition with a carrier, such as water (aqueous solution) through routes such as orally, topically, rectally, in body cavities, enema etc. with a daily dose, such as 10mg/Kg (so for a 50Kg patient, the dose is 500mg; reads on instant claim 72), 50mg/Kg, 100mg/Kg etc. (0020-0024, 2112, 2113, 2116, 2121-2125). Paragraph 2112-2113, 2116-2119, 2123, 2132, teach that amount of the compound that may be combined with a carrier material to produce a dosage form, such as powder, liquid, semi-solid, gel etc. will vary depending upon the host treated and the particular mode of administration.
Ascertaining the differences between the prior art and the claims at issue
Baker teaches applicants process using composition comprising same compound and a carrier as in the instant claims, but fails to teach amount of glycerol as carrier in the composition and working example of treating dysbiosis from diseases, such as celiac disease, inflammatory bowl disease.
Resolving the level of ordinary skill in the pertinent art
With regard to the above difference regarding amount of carrier in the composition- Baker teaches that amount of the compound that may be combined with a pharmaceutically acceptable carrier material to produce a dosage form, such as powder, liquid, semi-solid, gel etc. will vary depending upon the host treated and the particular mode of administration. Thus, based on the guidance of the cited prior art, it would have been prima facie obvious to a person of ordinary skill that the amount of carrier added to a composition may depend on a dosage form, such as powder, liquid, semi-solid, gel etc. and the particular mode of administration. For example, in a semi solid, amount of carrier will be less compared to a liquid form and it is a routine to make compositions of different consistency by varying carrier with a reasonable expectation of success to be useful in same process of the cited prior art.
With regard to the difference of carrier as glycerol- Baker teaches that the compound may be combined with known pharmaceutically acceptable carrier material. As provided by Pharmaceutical (pages 5- 7 and 21), glycerol is a commonly known pharmaceutical carrier for making both oral as well as enemas pharmaceutical composition. Thus, based on the guidance of the cited prior art, it would have been prima facie obvious to a person of ordinary skill that a common carrier such as glycerol may be useful in making the composition.
With regard to the difference of working example of treating dysbiosis from diseases, such as celiac disease, inflammatory bowel disease - Baker teaches that the composition may be useful in disrupting (reducing, dissolving etc.) a biofilm (dysbiosis) resulted from an allergic reaction (celiac disease is an allergic inflammation), inflammation, GI tract infection etc. and may be administered in combination with other agents (paragraphs 2033-2037; 2048-2065). Thus, based on the guidance of the cited prior art, it would have been prima facie obvious to a person of ordinary skill that dysbiosis of GI caused by any reason, such as celiac disease, inflammatory bowel disease etc. may be treated with the composition of the cited prior art.
Thus, the cited prior art meets all limitations of the instant claims.
Therefore, all the claimed elements were known in the prior art and one skilled person in the art could have modify the elements as claimed by known methods with no change in their respective functions, and would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Considering objective evidence present in the application indicating obviousness or nonobviousness
To establish a prima facie case of obviousness, three basic criteria must be met: (1) the prior art reference must teach or suggest all the claim limitations; (2) there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; and (3) there must be a reasonable expectation of success; and (MPEP § 2143).
In this case, Baker teaches applicants process using composition comprising same compound and a carrier. Pharmaceutical, teaches glycerol as a commonly known pharmaceutical carrier for making both oral as well as enemas pharmaceutical composition.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” (Id. At 1395). See MPEP 2143 - Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-9].
In this case at least prong (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success would apply.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at ___, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. Further, there is a reasonable expectation of success that the carrier such as 1%, 2% etc. may be combined with the compound to make a composition to be useful in same process as taught by the cited prior art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited references and to make the instantly claimed process with a reasonable expectation of success. Modifying such parameters is prima facie obvious because an ordinary artisan would be motivated to develop an alternative process for economic reasons or convenient purposes, and to arrive applicants process with a reasonable expectation of success, since it is within the scope to modify the process through a routine experimentation.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 22, 23, 42, 59, 62, 65, 66, 67 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12-14 of U.S. Patent No. 8,916,542.
The claims of the ‘542 Patent is directed towards a method of inhibiting the growth of a pathogenic bacterium (equivalent to treating dysbiosis, defined by the instant specification, paragraphs 0002-0006) by contacting the bacterium with a chitosan derivative of formula (I), comprising administering said compound, which is the same chitosan derivative as recited in instant claim 1. Claim 12 of the ‘542 Patent teaches the molecular weight ranges from about 25,000 da to 100,000 Da, which overlaps with the range of instant claim.
It would have been obvious at the time the invention was made to contact the claimed compound to treat dysbiosis in a subject for any reasons, such as inflammatory bowel disease etc.
Thus, the instant claims are prima facie obvious over claims 1 and 12-14 of the ‘542 Patent.
Claim 22-24, 38, 42, 44-45, 59, 62, 65, 66, 67 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7-10 of U.S. Patent No. 9,439,925.
Claim 1 of the ‘925 Patent is directed towards treating mucositis or ulceration (caused by pathogenic bacteria and imbalance of natural bacteria in GI tract) (equivalent to treating dysbiosis, defined by the instant specification, paragraphs 0002-0006) in the GI tract comprising administering an effective amount of a composition comprising the same compound as instantly claimed. Claim 4 of the ‘925 Patent teaches administering the composition topically or orally.
The disclosure of the ‘925 Patent teaches the compound has biofilm disruption properties (col. 132, lines 35-42).
It would have been obvious at the time the invention was made to contact the claimed compound with a biofilm caused by pathogenic bacteria and imbalance of natural bacteria (equivalent to treating dysbiosis, defined by the instant specification) in GI tract in a subject for treating inflammatory bowel diseases, such as mucositis and ulceration
Thus, the instant claims are prima facie obvious over claims 1-5 and 7-10 of the ‘925 Patent.
Response to Arguments
Applicants’ remarks and affidavit, filed on 01/16/2026, have been fully considered but not found persuasive.
Applicant argue that Baker does not disclose treatment of dysbiosis in a subject identified as having dysbiosis and a condition selected from a group consisting of inflammatory bowel disease etc. Applicant further argue that Pharmaceutical fails to cure deficiency of Baker as it is a broad disclosure for oral administration.
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This is not found persuasive and the instant claims are found obvious over the cited prior art. This is because Baker specifically teaches disrupting (reducing, dissolving etc.) a biofilm in the gut of the subject from unbalanced population of bacteria by reducing pathogenic bacteria (not harming useful bacteria, i.e. maintaining beneficial or diversity of commensal microflora in the gut), for example C. difficile etc. such as in GI tract with examples of such treatment (abstract, 0003-0017; 0025-0041, 0046, 0047, 0090-0095, 0100, 0133, 0191, 0617-0618, 1285, 2024-2037, 2042-2043, 2050-2065, 2113, 2115, 2116, 2024-2037, 2141-2147):
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(same as definition of dysbiosis as described by the instant specification paragraphs 0004-0006, 0049, 0051, 0052, 0053, 0054, 0059-0060; for example C. difficile etc.; see paragraph 0005).
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In fact, both the cited prior art and the instant specification teaches treating, same infections caused by same bacteria. Thus, contrary to applicant’s argument, Baker not only teaches treating dysbiosis but also provides bacteria involved and diseases leading to dysbiosis, such as GI infection causing inflammation, immunocompromised patients (i.e., patients received chemotherapy and have dysbiosis), oral infection etc. Just because Baker teaches method of treating a subject with full definition of dysbiosis (which is exactly same definition provided by the instant specification for dysbiosis) instead of using dysbiosis, does not imply that Baker does not teach method of treating in a subject identified with the disease. Thus, Baker in fact does teaches a subject identified as having dysbiosis and treating dysbiosis in the subject. Additionally, dysbiosis is caused by a reason/ disease or a condition as it is not natural and healthy to have dysbiosis, such as C. difficile, inflammation of GI tract, allergic reaction (celiac is an allergic reaction). The cited prior art discloses that the composition may be useful in disrupting (reducing, dissolving etc.) a biofilm resulted from an allergic reaction, inflammation, GI tract infection etc. and may be administered in combination with other agents (paragraphs 2033-2037; 2048-2065). Thus, based on the guidance of the cited prior art, it would have been prima facie obvious to a person of ordinary skill that dysbiosis of GI caused by any reason, such as celiac disease, inflammatory bowel disease etc. may be treated with the composition of the cited prior art. This is because Baker teaches treating dysbiosis caused by inflammation of GI tract and/or allergic reaction. Since Baker does teaches subject identified as having dysbiosis and treating dysbiosis in the subject, Pharmaceutical doesn’t have to cure this deficiency. Baker’s extra teaching of treating dysbiosis in cystic fibrosis patients doesn’t preclude Baker’s teaching of treating of dysbiosis in patients with GI inflammation caused by diseases such as GI infection and or dysbiosis in immunocompromised patients and importantly caused by same microbes.
Applicant argued over unexpected results and discussed example 4 of treating necrotic enteritis in broiler chicks infected with bacteria equivalent of C diff in humans causing G.I. infection with a specific dose. Applicant also argued over example 9 preventing colitis using a specific dose. Applicant argued using figure 11-14 about treating edema and mucosal necrosis etc.
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This is not found persuasive and the instant claims are found obvious over the cited prior art. This is because Baker teaches treating infection caused by C diff in humans causing GI infection and inflammation, mucosal necrosis as well as GI infection leading to diarrhea, pain and blood in stool (colitis):
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Thus, applicant’s result is not unexpected but expected as taught by the cited prior art. Further, applicant is arguing over a narrow limitation of dose, which is not recited in the instant claims. The broad limitation of amount of the instant claim 46 is also taught by the cited prior art.
Applicant argued in the affidavit that the treatment of dysbiosis----that allow select bacteria to thrive and prevent harmful bacteria whereas Baker disrupts bacteria or biofilm.
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Applicant provided new reference, Mitra (published in 2025) and argued that provide experimental confirmation that the compound MIIST305 recited in the instant claims increased microbial diversity and restored abundance of specific commensal bacteria by reducing specific harmful bacteria:
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This is not found persuasive and the instant claims stand rejected. This is because contrary to affidavit and applicants argument, Baker specifically teaches disrupting (reducing, dissolving etc.) a biofilm in the gut of the subject from unbalanced population of bacteria by reducing pathogenic bacteria (not harming useful bacteria, i.e. maintaining beneficial or diversity of commensal microflora in the gut), for example C. difficile etc. such as in GI tract with examples of such treatment (abstract, 0003-0017; 0025-0041, 0046, 0047, 0090-0095, 0100, 0133, 0191, 0617-0618, 1285, 2024-2037, 2042-2043, 2050-2065, 2113, 2115, 2116, 2024-2037, 2141-2147):
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(same as definition of dysbiosis as described by the instant specification paragraphs 0004-0006, 0049, 0051, 0052, 0053, 0054, 0059-0060; for example C. difficile etc.; see paragraph 0005).
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In fact, both the cited prior art and the instant specification teaches treating, same infections caused by same bacteria. Thus, contrary to applicant’s argument, Baker not only teaches treating dysbiosis but also provides bacteria involved and diseases leading to dysbiosis, such as GI infection causing inflammation, immunocompromised patients (i.e., patients received chemotherapy and have dysbiosis), oral infection etc. Just because Baker teaches method of treating a subject with full definition of dysbiosis (which is exactly same definition provided by the instant specification for dysbiosis) instead of using dysbiosis, does not imply that Baker does not teach method of treating in a subject identified with the disease.
With regards to applicant’s argument over a new reference, that is after the filing date of the instant application, is again not found persuasive and the instant claims stand rejected. This is because (1) if the applicants need office to consider a reference, the ref needs to be provided in appropriate IDS form; (2) Baker specifically teaches disrupting (reducing, dissolving etc.) a biofilm in the gut of the subject from unbalanced population of bacteria by reducing pathogenic bacteria (not harming useful bacteria, i.e. maintaining beneficial or diversity of commensal microflora in the gut), for example C. difficile etc. such as in GI tract with examples of such treatment. Thus, teaching of using PAAG of formula I in reducing harmful bacteria while maintaining beneficial bacteria is taught by Baker; (3) If applicant intends to show evidence with respect to reducing specific bacteria while not affecting specific bacteria, it is in fact a new matter. Further, the instant claims have no such limitations on such bacteria and thus applicant is arguing over a limitation not recited in the instant claims; (4) Applicant only argued over the reference and structure of compound MIIST305, but provided no verification that the compound of the reference is the compound of the cited prior art and the compound of the instant claims (as the compound of the cited prior art is exactly same as in the instant claims).
Applicant in affidavit argued that biofilm can contain many microorganisms, such as bacteria, fungi etc.
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This is not found persuasive and the instant claims stand rejected. This is because the instant specification also recites that dysbiosis results different types of microorganisms, such as fungi, yeast etc. (0052).
Applicant didn’t argue over ODP rejection, thus, the rejection is maintained.
Conclusion
No Claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PANCHAM BAKSHI whose telephone number is (571)270-3463. The examiner can normally be reached M-Thu 7-4.30 EST.
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/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623
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