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 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.
Election/Restrictions
Applicants elected the composition of table 2 without traverse in the reply filed on 26 Sept, 2024 and the phone call with Nick Baumann, applicant’s representative, on 2 Oct, 2024.
Claims Status
Claims 1-3, 14-26, and 31-34 are pending.
Claims 1, 22, 23, and 26 have been amended.
Claims 31-34 are new.
Claims 24 and 34 have been withdrawn due to an election/restriction requirement.
Examiner’s Note
The clay in applicant’s elected formulation, laponite, is a magnesium silicate, not an aluminosilicate (note the PubChem page for laponite, downloaded 24 March, 2026), so claim 34 is properly withdrawn.
In addition, prior art and double patenting rejections have been withdrawn due to amendment to include limitations that are not enabled, as it is not proper to reject a claim as not being enabled, then further reject it saying the prior art/competing claims show someone did it. However, once the enablement rejection is overcome, these rejections may reappear.
Withdrawn Rejections
The rejection of claim(s) 1-3, 14-23, and 25-29 under 35 U.S.C. 103 as being unpatentable over Minerath et al (US 6,551,607) in view of Stroebech (WO 2017190752, cited by applicants), and Langguth et al (US 20050142175), with evidentiary support from the Ineos spec sheet for Indopol H-300 (2018) is hereby withdrawn due to amendment.
The rejection of claims 1-3 and 14-21 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 11,583,484 in view of Stroebech (WO 2017190752, cited by applicants) is hereby withdrawn due to amendment.
The rejection of claims 1-3 and 14-21 on the ground of nonstatutory double patenting as being unpatentable over claims 1 6, and 10 of U.S. Patent No. 11,911,310 is hereby withdrawn due to amendment.
The rejection of claims 1-3 and 14-21 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 13 of U.S. Patent No. 11,291,578 is hereby withdrawn due to amendment.
The rejection of claims 1-3 and 14-21 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 12, and 14 of U.S. Patent No. 11,491,254 is hereby withdrawn due to amendment.
The rejection of claims 1-3 and 14-21 on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9-11 of U.S. Patent No. 11,786,631 is hereby withdrawn due to amendment.
The rejection of claims 1-3 and 14-21 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, and 12 of U.S. Patent No. 11,583,431 in view of Stroebech (WO 2017190752, cited by applicants) is hereby withdrawn due to amendment.
The rejection of claims 1-3 and 14-21 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14, and 15 of U.S. Patent No. 11,547,598 in view of Stroebech (WO 2017190752, cited by applicants) is hereby withdrawn due to amendment.
The rejection of claims 1-3 and 14-21 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14, and 15 of U.S. Patent No. 11,547,598 in view of Stroebech (WO 2017190752, cited by applicants) is hereby withdrawn due to amendment.
The rejection of claims 1-3 and 14-21 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 16, and 17 of U.S. Patent No. 11,534,326 in view of Stroebech (WO 2017190752, cited by applicants) is hereby withdrawn due to amendment.
The rejection of claims 1-3 and 14-21 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 9 of U.S. Patent No. 11,903,867 in view of Stroebech (WO 2017190752, cited by applicants) is hereby withdrawn due to amendment.
The rejection of claims 22, 23, 28, and 29 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph due to uncertainty as to what a “dough like texture” consisted of is hereby withdrawn due to amendment.
New Objections
Claim Objections
Claim 26 is objected to because of the following informalities: the last word of the claim is “and,” which appears to be a typo, as it is not grammatically correct. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “configured to” in claims 1 and 33.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 26 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 26, and claims dependent on it, describe a formulation with potato protein, some solid, and a polybutene, all at specific percentages. However, there is no support in the disclosure for these limitations. Applicants point to table 2, which gives an example of a formulation that meets the limitations of the claims for support. However, a species does not define a genus (MPEP 2144.08), so this specific example does not support the much broader genus claimed. Thus, these limitations are new matter.
response to applicant’s arguments
Applicants point to table 2 of the disclosure for support.
Applicant's arguments filed 4 March, 2026 have been fully considered but they are not persuasive.
Applicants point to an example of the genus that they are claiming in their disclosure, but there is no evidence that they intended to cover the genus of the claim. As noted in the rejection, a species is not typically sufficient to render a genus obvious, and, even if it did, limitations that are obvious from the disclosure are not sufficient to provide written description (Regents of the Univ. of Cal. v Eli Lilly & Co 777 F. Supp. 779).
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 23 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 23 require that the texture of the material will substantially prevent liquid exudation. It is not clear how the texture of the material will prevent liquid separation, nor is it clear what sort of test is conducted for liquid exudation. Compression under gravity is a very different test than compression via ultracentrifugation, for example.
response to applicant’s arguments
Applicants have amended the claim language.
Applicant's arguments filed 4 March, 2026 have been fully considered but they are not persuasive.
Applicants have replaced “syneresis” with “help prevent exuding of liquid,” which is essentially what syneresis is. It is not clear how this overcomes the rejection.
New Rejections
Claim Rejections - 35 USC § 112(a)
The legal basis for rejections under this statute was given above, and will not be repeated here.
first rejection, enablement.
Claims 1-3, 14-23, 25, 26, and 31-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The MPEP states “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is ‘undue.’ These factors include, but are not limited to: 1) the breadth of the claims; 2) the nature of the invention; 3) the state of the prior art; 4) the level of one of ordinary skill; 5) the level of predictability in the art; 6) the amount of direction provided by the inventor; 7) the existence of working examples; and 8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure” (MPEP 2164.01(a).
1 and 2) the breadth of the claims and the nature of the invention: Applicants are claiming a composition intended for ostomy use, comprising potato protein, clay, and a liquid non-polar polymer, where the potato protein delays wetting of the composition.
3) the state of the prior art: Not used in this rejection
4) the level of one of ordinary skill: The level of skill in the art is high.
5) the level of predictability in the art: Applicants have been arguing unexpected results for several rounds of prosecution; this indicates a lack of predictability in the art.
6 and 7) the amount of direction provided by the inventor and the existence of working examples: There is a paragraph using the same language as the claim (3d page, 3d paragraph), but no examples demonstrating potato protein slowing wetting of the composition.
8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure: Applicants have claimed a formulation where a component of the formulation slows the wetting of the formulation when exposed to stomal output. However, the composition is exposed, so already wetted; it is physically impossible for a composition to be both wet and not wet at the same time. Thus, it will take undue experimentation to make the composition as claimed.
second rejection, new matter
Claims 1-3, 14-23, 25, 26, and 31-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1, and claims dependent on it, has a limitation that the potato protein be configured to reduce the rate of swelling of the composition. There is no mention of reducing the rate of swelling of the composition in the disclosure, so this amendment is new matter.
Claim Rejections - 35 USC § 112(b)
The legal basis for rejections under this statute was given above, and will not be repeated here.
second rejection
Claims 1-3, 14-23, 25, 26, and 31-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, and claims dependent on it, require a comparison to “a composition with less than 15 weight% potato protein.” However, this composition is not defined in any way, save by a maximum amount of potato protein. For example, whole (2% protein) potatoes (2% protein) s fit this limitation (Arnarson et al, Healthline article on potatoes (2025), 4th page, 1st paragraph), which would not be expected to swell at all. In addition, the test is not defined by applicants. A composition exposed to 35 µL of stomal output might give a different result than the same composition exposed to 100 mL, or at a different temperature, or other parameters. Note that claims 31-33 have similar limitations with similar issues.
third rejection
Claims 22 and 33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 22 and 33 have limitations on the texture affecting the flow of the composition. It is not clear how these two features are related. Texture is a feature of solids; the flow is related to viscosity; a property of liquids. It is thus unclear what the limitations of these claims are.
fourth rejection
Claim 32 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 32 describes the pressure applied onto a stoma; this is a function of parameters not described by the claim, such as how the material is applied, how tight any bandages or adhesive are bound, etc. If one test shows an embodiment meets these claim limitations, and another does not, it is not clear if the claim limitations have been met.
fifth rejection
Claims 1-3, 14-23, 25, 26, and 31-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 33 have the limitation “configured to,” which invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. For claim 1 (and claims dependent on it), the functional language is both new matter, and not enabled, so there are no embodiments that have these claim limitations. For claim 33, there is no description of any embodiment of the claims under any conditions where it will flow. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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