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 with traverse of Group I, claims 1-5, in the reply filed on 11/10/25 is acknowledged. The traversal is on the ground(s) that the special technical feature makes a contribution over the art. This is not found persuasive for the reasons of record (see further the rejection of the claimed invention below)- note that applicant’s characterization of the special technical feature is more specific than is claimed in all the groups.
The requirement is still deemed proper and is therefore made FINAL.
Claims 6-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/10/2025.
Information Disclosure Statement
37 CFR § 1.56 - Duty to disclose information material to patentability .
(a) A patent by its very nature is affected with a public interest. The public interest is best served, and the most effective patent examination occurs when, at the time an application is being examined, the Office is aware of and evaluates the teachings of all information material to patentability. Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section. The duty to disclose information exists with respect to each pending claim until the claim is cancelled or withdrawn from consideration, or the application becomes abandoned. Information material to the patentability of a claim that is cancelled or withdrawn from consideration need not be submitted if the information is not material to the patentability of any claim remaining under consideration in the application. There is no duty to submit information which is not material to the patentability of any existing claim. The duty to disclose all information known to be material to patentability is deemed to be satisfied if all information known to be material to patentability of any claim issued in a patent was cited by the Office or submitted to the Office in the manner prescribed by § 1.97(b) - (d) and 1.98. However, no patent will be granted on an application in connection with which fraud on the Office was practiced or attempted or the duty of disclosure was violated through bad faith or intentional misconduct. The Office encourages applicants to carefully examine:
(1) prior art cited in search reports of a foreign patent office in a counterpart application, and
(2) the closest information over which individuals associated with the filing or prosecution of a patent application believe any pending claim patentably defines, to make sure that any material information contained therein is disclosed to the Office.
(b) Under this section, information is material to patentability when it is not cumulative to information already of record or being made of record in the application, and
(1) It establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim; or
(2) It refutes, or is inconsistent with, a position the applicant takes in:
(i) Opposing an argument of unpatentability relied on by the Office, or
(ii) Asserting an argument of patentability.
A prima facie case of unpatentability is established when the information compels a conclusion that a claim is unpatentable under the preponderance of evidence, burden - of - proof standard, giving each term in the claim its broadest reasonable construction consistent with the specification, and before any consideration is given to evidence which may be submitted in an attempt to establish a contrary conclusion of patentability.
(c) Individuals associated with the filing or prosecution of a patent application within the meaning of this section are:
(1) Each inventor named in the application;
(2) Each attorney or agent who prepares or prosecutes the application; and
(3) Every other person who is substantively involved in the preparation or prosecution of the application and who is associated with the inventor, with the assignee or with anyone to whom there is an obligation to assign the application.
(d) Individuals other than the attorney, agent or inventor may comply with this section by disclosing information to the attorney, agent, or inventor.
[42 FR 5593, Jan. 28, 1977; paras. (d) & (e) - (i), 47 FR 21751, May 19, 1982, effective July 1, 1982; para. (c), 48 FR 2710, Jan. 20, 1983, effective Feb. 27, 1983; paras. (b) and (j), 49 FR 554, Jan. 4, 1984, effective Apr. 1, 1984; paras. (d) and (h), 50 FR 5171, Feb. 6, 1985, effective Mar. 8, 1985; para. (e), 53 FR 47808, Nov. 28, 1988, effective Jan. 1, 1989; 57 FR 2021, Jan. 17, 1992, effective Mar. 16, 1992]
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.
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.
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) 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Oben 2007/0202204 and Sanofi 2016/0235818.
Oben discloses a method of treatment for intestinal issues in a subject the method comprises: evaluating an origin of a lipase and/or an amylase from a biological fluid sample from the subject (including the use of biomarker as in claim 2) [0017]-[0028], inhibits salivary amylase activity, inhibits intestinal amylase activity, inhibits intestinal lipase activity; optionally analyzing a level of the lipase and/or an amylase from the biological fluid sample from the subject; imaging a colon and a pancreas of the subject; and providing laxatives, an anti-fungal composition, fat, a composition selected from a group comprising glucosamine, methylsulfonylmethane (MSM) rhamnan sulfate, Sulodexide, Rosuvastatin, Metformin, Hydrocortisone, Antithrombin, Etanercept, Heparin, Albumin, Fresh frozen plasma (FFP), Poloxamer-188, vitamins [0014], the composition also includes one or more amylase inhibiting compounds and/or one or more antioxidants such as vitamins A, C, or E), trace elements, a locally acting vasodilator, anaerobic microbial culture, pickled fruits, pickled vegetables, preserved meat, and fermented juices or a combination thereof based upon results the analysis.
Oben does not teach the imaging (as in claim 3) however it would have been obvious at the time the invention was made to use imaging to pancreas in the invention of Oben because Sanofi-Aventis imaging of the pancreas is done by the way of magnetic resonance imaging (MRI), X-Ray, CT-scan, ultrasound, thermal imaging, nuclear imaging, physical exam, or a combination thereof [0513] [0514] to determine suspected pancreatitis. Sanofi indicates that the diagnosis of pancreatitis may be supposed also if other causes of abdominal pain are excluded (i.e., gallbladder disease, etc) and elevated amylase/lipase is seen and in addition pancreatic changes are seen on ultrasound and/or CT or MRI (with contrast, as appropriate)).
Applicant is directed to pages 12-13 of KSR v Teleflex (500 US 398 2007) “ … the Court has held that a “patent for a combination which only unites old elements with no change in their respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.” Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U. S. 147, 152 (1950). This is a principal reason for declining to allow patents for what is obvious. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” “When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one(emphasis added). If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”
Oben and Sanofi teach a large variety of treatments for colon failure but not specifically the fat treatments as in claim 4 or the fiber diet as in claim 5 however it would have been obvious at the time the invention was field to use any conventional colon failure treatment including giving the patients beneficial fats and fibers as doing so would only unite known elements with no change in their respective functions and provide a reasonable expectation of treatment.
Accordingly, the claimed invention was prima facie obvious to one of ordinary
skill in the art at the time the invention was filed especially in the absence of evidence
to the contrary.
Claim(s) 1-2 &4 are rejected under 35 U.S.C. 103 as being unpatentable over Oben and Anabio 2021/0077386.
Oben discloses a method of treatment intestinal issues in a subject the method comprises: evaluating an origin of a lipase and/or an amylase from a biological fluid sample from the subject (including the use of biomarker as in claim 2) [0017]-[0028], inhibits salivary amylase activity, inhibits intestinal amylase activity, inhibits intestinal lipase activity; optionally analyzing a level of the lipase and/or an amylase from the biological fluid sample from the subject; imaging a colon and a pancreas of the subject; and providing laxatives, an anti-fungal composition, fat, a composition selected from a group comprising glucosamine, methylsulfonylmethane (MSM) rhamnan sulfate, Sulodexide, Rosuvastatin, Metformin, Hydrocortisone, Antithrombin, Etanercept, Heparin, Albumin, Fresh frozen plasma (FFP), Poloxamer-188, vitamins [0014], the composition also includes one or more amylase inhibiting compounds and/or one or more antioxidants such as vitamins A, C, or E), trace elements, a locally acting vasodilator, anaerobic microbial culture, pickled fruits, pickled vegetables, preserved meat, and fermented juices or a combination thereof based upon results the analysis.
Oben does not expressly teach wherein the fat is selected from a group consisting of non-absorbable fats, wax esters, fat from butter fish, or a combination thereof, however Anabio teaches the fat treatment for colon maladies can include of non-absorbable fats, wax esters, fat from butter fish and combinations thereof [0144]. Anabio teaches a dose of encapsulated lipid made according to the methods strong bowel movements are initiated.
Accordingly, the claimed invention was prima facie obvious to one of ordinary
skill in the art at the time the invention was filed especially in the absence of evidence
to the contrary.
Claim(s) 1-2 & 5 are rejected under 35 U.S.C. 103 as being unpatentable over Oben and Ho (from ISR).
Oben discloses a method of treatment for intestinal issues in a subject the method comprises: evaluating an origin of a lipase and/or an amylase from a biological fluid sample from the subject (including the use of biomarker as in claim 2) [0017]-[0028], inhibits salivary amylase activity, inhibits intestinal amylase activity, inhibits intestinal lipase activity; optionally analyzing a level of the lipase and/or an amylase from the biological fluid sample from the subject; imaging a colon and a pancreas of the subject; and providing laxatives, an anti-fungal composition, fat, a composition selected from a group comprising glucosamine, methylsulfonylmethane (MSM) rhamnan sulfate, Sulodexide, Rosuvastatin, Metformin, Hydrocortisone, Antithrombin, Etanercept, Heparin, Albumin, Fresh frozen plasma (FFP), Poloxamer-188, vitamins [0014], the composition also includes one or more amylase inhibiting compounds and/or one or more antioxidants such as vitamins A, C, or E), trace elements, a locally acting vasodilator, anaerobic microbial culture, pickled fruits, pickled vegetables, preserved meat, and fermented juices or a combination thereof based upon results the analysis.
Oben fails to explicitly disclose further comprises alternating between fiber and fiber free diet wherein fiber diet comprises of dietary and supplemental fiber however it would have been obvious to do so because Ho teaches alternating between fiber and fiber free diet wherein fiber diet comprises of dietary and supplemental fiber (Pg. 4593, right column, first full paragraph) to improve colon function and also treat constipation.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); >see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");< ** In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Accordingly, the claimed invention was prima facie obvious to one of ordinary
skill in the art at the time the invention was filed especially in the absence of evidence
to the contrary.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
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/BLAINE LANKFORD/ Primary Examiner, Art Unit 1657