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 .
DETAILED ACTION
This Office Action is in response to Applicant’s Arguments filed 02/02/2026.
Claims 1-20 are pending.
Priority
This application claims the following priority:
PNG
media_image1.png
89
656
media_image1.png
Greyscale
Election/Restrictions
Applicant’s elected Group III, a method of treating a disease, and the species a) inflammatory bowel disease as the disease, and b) administering an agonist or an antagonist of a muscarinic acetylcholine receptor to a subject to be treated, as the type of regulating the amount of peripheral regulatory T cells in the gut, in the reply filed on 08/04/2025.
Claims 1-11 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
Claims 12-19 are examined on the merits herein.
REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
Specification Objections
Applicant’s amendment to the specification is sufficient to overcome this objection.
REJECTIONS MAINTAINED
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 12-17 and 19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being
anticipated by US 2017/0246267 to Wang (published 2017, PTO-892 of 10/06/2025).
Regarding claims 12-13, 15, and 17, Wang teaches treating gastric cancer, colon cancer, colitis, or gastritis in a subject by administering a cholinergic agonist or antagonist (pg. 45, claims 1-7), wherein the cholinergic antagonist is specifically taught as a muscarinic receptor antagonist (pg. 45, claims 10-11).
Regarding claims 12-16, Wang additionally teaches a method for stimulating regeneration of the colon or stomach in a subject with inflammatory bowel disease by administering a cholinergic agonist, wherein the cholinergic agonist is pilocarpine or bethanechol (pgs. 45-46, claims 5, 23, 24).
Regarding claim 19, Wang teaches that “subject” includes all members of the animal kingdom including, but not limited to, mammal, animals, and humans ([0089]).
Further regarding claim 12, while Wang does not explicitly teach “by regulating an amount of peripheral regulatory T cells in the gut,” it is reasonable to assume that the method of Wang would have the same properties since it administers the same active agent (a muscarinic agonist or antagonist, and specifically, pilocarpine or bethanechol) for the same purpose (treating patients with inflammatory bowel disease, cancer or gastrointestinal infection) in the same amount (Wang teaches an amount of a compound that is sufficient to effect beneficial or desired results ([0087]), and the instant specification does not teach a specific amount), to the same population (patients with inflammatory bowel disease), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties. See also MPEP 2112.02.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
See also MPEP 2112.02.
Claims 12 and 17-19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 6,310,103 to Aberg (published 2001, PTO-892).
Aberg teaches a method of treating urinary incontinence or gastrointestinal hyperactivity in a mammal by administering S(-)-2-[α-[2-diisopropylamino)ethyl]benzyl]-p-cresol, i.e., tolterodine (Col. 6, claims 1-2, Col. 1, lines 9-36).
Regarding claim 19, mammal encompasses both human and non-humans.
While Aberg does not explicitly teach “by regulating an amount of peripheral regulatory T cells in the gut,” it is reasonable to assume that the method of Aberg would have the same properties since it is administered for the same purpose (treating a disease in the gut that is treated by administering an antagonist of a muscarinic acetylcholine receptor, see pg. 10 of the Specificaiton) in the same amount (Aberg teaches a therapeutically effective amount as an amount sufficient to treat the disease, but insufficient to cause adverse effects (Col. 3, lines 1-9), and the instant specification does not teach a specific amount), to the same patient population (patients with a disease of the gut that is treated by administering an antagonist of a muscarinic acetylcholine receptor), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
See also MPEP 2112.02.
Claims 12-13 and 17-18 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 2004/0136915 to Dugger (published 2004, PTO-892).
Dugger teaches a method of treating diarrhea associated with mild dysentery, i.e., a gastrointestinal infection, in a patient, comprising administering a composition comprising atropine (pgs. 13-19, claims 1, 11, 22, 29, 46, 68, 90, 112, 129, 137, 150, 172).
While Dugger does not explicitly teach “by regulating an amount of peripheral regulatory T cells in the gut,” it is reasonable to assume that the method of Dugger would have the same properties since it is administered for the same purpose (treating a gastrointestinal infection, i.e., dysentery) in the same amount (Dugger teaches a dose that is less than the standard accepted dose since there is enhanced absorption of the compounds through the oral mucosa ([0040]), wherein 25-500mcg, 10-20 mcg/kg, 500-600 mcg, and 20 mcg/kg are exemplified as some standard doses ([0009]-[0010]), and the instant specification does not teach a specific amount), to the same patient population (patients with a gastrointestinal infection), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
See also MPEP 2112.02.
Response to Arguments
On pg. 8, Remarks, Applicant summarizes the statutory requirements of 35 USC 102.
On pg. 9, Remarks, Applicant argues that under proper claim interpretation, anticipation requires that the references discloses expressly or inherently, a method in which disease treatment is carried out through immune regulation of gut peripheral regulatory cells.
On pg. 9, Remarks, Applicant further argues that “the Office Action effectively treats claim 12 as merely identifying an unappreciated property of known treatment methods. That characterization is incorrect. The claims do not recite that administration of a muscarinic ligand happens to result in immune effects; they require a method of treatment carried out by regulating an amount of peripheral regulatory T cells in the gut. Immune regulation is the operative step of the method, not a descriptive afterthought. The cited references, by contrast, disclose methods directed to non-immune therapeutic objectives.”
These arguments have been fully considered, but are not found persuasive. As discussed in detail in the above rejections, the cited prior art references inherently “regulate an amount of peripheral regulatory T cells in the gut.”
The prior art references teach a method of treating the same diseases, as instantly claimed and/or as elected as species, by administering, in amounts therapeutically effective to treat these diseases, the same agonists/antagonists of a muscarinic acetylcholine receptor, as instantly claimed and as elected as species. As such, absent evidence to the contrary, the prior art references would necessarily treat the disease by “regulating an amount of peripheral regulatory T cells in the gut.” See MPEP 2112.02, “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.”
Regarding the preamble “for treating a disease by regulating an amount of peripheral regulatory T cells in the gut,” the following is respectfully pointed out:
The determination of whether a preamble limits a claim is made on a case-by-case basis in light of the facts in each case; there is no litmus test defining when a preamble limits the scope of a claim. MPEP § 2111.02 (citing Catalina Mktg. Int’l v. Coolsavings.com, Inc., 289 F.3d 801, 808, 62 USPQ2d 1781, 1785 (Fed. Cir. 2002)).
As a general rule preamble language is not treated as limiting. Arctic Cat Inc. v. GEP Power Prods., Inc., 919 F.3d 1320, 1327 (Fed. Cir. 2019). Exceptions arise where, for example, the preamble (1) recites essential structure or steps; (2) provides antecedent basis for terms in the claim body; or (3) was relied on during prosecution to distinguish the claimed invention from prior art. Catalina Mktg. Int’l, Inc. v. Cool savings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002).
Note also, that claim scope is not limited by claim language that does not limit a claim to a particular structure. MPEP § 2111.04 (citing In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005).
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. MPEP § 2112.02(II) (citing Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation")).
As stated above, in the instant case, the prior art teaches a method of treating the same diseases, as instantly claimed and/or elected, by administering the same the same active ingredient as instantly claimed and elected, to the same patient population as that taught by the instant specification and claims, in amounts effective to treat the diseases. As such, the prior art teaches the same steps as instantly claimed administered to the same patient population, and therefore necessarily “regulates an amount of peripheral regulatory T cells in the gut.”
While the instant invention may have discovered a new property of a known method of treatment, it is respectfully pointed out that MPEP 2145(II) states, “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. . .’The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.’”
Regarding the arguments on the bottom of pg. 9, Remarks, it is not clear how the “cited references. . .disclose methods directed to non-immune therapeutic objectives.” As stated above, the cited references teach the treatment of the same diseases by administering the same active ingredients to the same patient populations. It is not clear what “non-immune therapeutic objectives” are, and how the cited references are directed to these objectives. Moreover, it is not clear how a method of treating a disease is a “non-immune therapeutic objective.”
On pg. 10, Remarks, Applicant argues that the premise that administering the same muscarinic agents for the treatment of the same diseases in therapeutically effective amounts, is insufficient to establish anticipation that it regulates T cells in the gut, and argues that “therapeutic indication is not therapeutic mechanism. Treating inflammatory bowel disease, cancer, dysentery, urinary incontinence, or gastrointestinal hyperactivity does not equate to treating by immune tolerance modulation via gut pTregs. Different biological mechanisms may address the same condition.”
These arguments have been fully considered, but are not found persuasive. First, it is respectfully pointed out that the instant claims do not recite “treating by immune tolerance modulation via gut pTregs.” Second, the examiner agrees that different biological mechanisms may address the same condition.
However, absent evidence to the contrary, since the prior art references teach the same method steps and teach administration to the same patient population, these methods would have the same effects, as instantly claimed.
On pg. 10, Remarks, Applicant argues that a “therapeutically effective amount” is endpoint-specific and that a dose sufficient to produce regeneration, smooth muscle effects, motility control, or symptomatic relief is not necessarily sufficient to regulate immune cell populations in the gut.
This argument has been fully considered, but is not found persuasive. First, it is respectfully pointed out that the instant claims do not recite any amount of “an agonist or an antagonist of a muscarinic acetylcholine receptor” to be administered. And as discussed in the above rejections, the instant specification and claims do not teach any amount of “an agonist or an antagonist of a muscarinic acetylcholine receptors” to be administered, let alone an amount that is critical to its methods. As such, since the prior art teaches administering the same compounds to treat the same diseases, as instantly claimed and elected, in amounts effective to treat these diseases, absent evidence to the contrary, it would necessarily “regulate an amount of peripheral regulatory T cells in the gut.”
On pg. 10, Remarks, Applicant argues that “the pleiotropic activity of muscarinic agonists and antagonists further undermines any inherency theory. Multi-target physiological effects make it less-not more-likely that a particular immune outcome is necessarily achieved whenever the prior art methods are practiced.”
This argument has been fully considered, but is not found persuasive. Applicant is respectfully reminded that the arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. See MPEP 716.01(c).
Applicant has not provided any evidence that the methods of the prior art, which teach the same methods steps, would not have the same effects.
For these reasons, Applicant’s arguments are not sufficient to overcome the instant rejections.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. 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.
/LAUREN WELLS/Examiner, Art Unit 1622
Prosecution Insights