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
Status of the application
Receipt of applicant’s amended claims filed on 05/23/2024 is acknowledged and examined in this office action. Since claims filed on later date, which is 06/02/2025, belongs to different application as per applicants agent, and so, are not considered or examined in this application. See attached Interview Summary.
Examiner also acknowledges applicants agent Beth L. Smiley, kindly providing species, viz., ‘treating’ and ‘Crohn’s disease’, for the claimed method, in a voice mail left on 01/20/2026. See Election/Restriction below. Examiner is grateful to applicants agent for her prompt response.
In this office action claims 1-6 are examined in light of ‘elected species’ on merits.
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
Genus Species
Method treating or preventing.
Gastrointestinal diseases ulcerative colitis or Crohn’s disease.
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following claim(s) are generic: all are generic.
During a telephone conversation with Beth Smiley on 01/20/2026 a provisional election of species, viz., treating and Crohn’s disease, was made to prosecute the invention. Affirmation of this election must be made by applicant in replying to this Office action.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Specification / Sequence Non-compliance
The disclosure is objected to because of the following informalities:
37 CFR 1.821(c) states that amino acid sequences encompassed by the sequence rules should be disclosed in a sequence listing and 37 CFR 1.821(d) states that the corresponding sequences should be identified by sequence identifier. In the instant case, specification recites amino acid sequence which is encompassed by the sequence rules. However, no sequence listing is provided. Appropriate correction is required.
Claim objections
Claim 1 is objected to because of the following informalities: colon (:) is missing in the “SEQ ID NO 1”. It should be “SEQ ID NO:1”. Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Written Description
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.
Claims 1-6 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 for the claimed method. 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The rejection is based on the requirement(s), i.e., the guidelines provided by the MPEP 2163.04. These are listed below:
(A) identify the claim(s) limitations at issue, and
(B) establish a prima facie case by providing reasons why a person skilled in the art at the time the application was filed would not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed. The MPEP 2163 further provided or expanded the guidelines for the written description requirements.
(A) IDENTIFY THE CLAIM LIMITATIONS AT ISSUE:
In light of elected species, claims are drawn to a method of treating Crohn’s disease comprising administering a pharmaceutical composition comprising a peptide containing amino acid sequence indicated by SEQ ID NO:1 with the recited limitations.
In addition to absence of shown data or description for treating Crohn’s disease, claims are broad with respect mode of administration, that means all possible administrations. Claims are also broad with respect to subject population, that means all possible non-human and human subjects. Claims are broad with respect dosage amounts.
Shown data in the specification is limited to ulcerative colitis. Also, there is no description in the specification on ‘how shown data of ulcerative colitis’ can be extrapolated to treat Crohn’s disease.
Though both Crohn’s disease and ulcerative disease are inflammatory bowel diseases, but they differ in the depth of inflammation and location/pattern. Crohn’s can be anywhere in the body, such as mouth, small/large intestine etc., whereas ulcerative colitis can be seen only in the large intestine, always starting at the rectum and moving up continuously. Depth of inflammation in Crohn’s is transmural, i.e., affects all layers of the bowel wall, whereas ulcerative colitis is limited to the inner most lining (mucosa).
In light of differences, (i) did applicants provide enough description for treating Crohn’s disease by administering SEQ ID NO:1? (ii) will the shown data on ulcerative colitis be capable to work for treating Crohn’s disease? (iii) did applicants describe or show evidence for nexus between treating Crohn’s disease and ulcerative colitis by administering SEQ ID NO:1? Based (i) to (iii), will a skilled person in the art understand claimed invention and can reproduce applicants claimed invention?
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include "level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient" (MPEP 2163).
(B) ESTABLISH A PRIMA FACIE CASE BY PROVIDING REASONS WHY A PERSON SKILLED IN THE ART AT THE TIME THE APPLICATION WAS FILED WOULD NOT HAVE RECOGNIZED THAT THE INVENTOR WAS IN POSSESSION OF THE INVENTION AS CLAIMED IN VIEW OF THE DISCLOSURE OF THE APPLICATION AS FILED:
The further analysis for adequate written description considers, see MPEP 2163, the following:
(A) Determine whether the application describes an actual reduction to practice of the claimed invention:
Not provided. Shown data in the specification is limited to ulcerative colitis. Also, there is no description in the specification on ‘how shown data of ulcerative colitis’ can be extrapolated to treat Crohn’s disease. The dosage range information have not been provided to the peptides. Further, it is completely generic.
Example 1 describes transanal administration experiment on inflammatory bowel disease-induced mouse and associated with ulcerative colitis. Example 2 describes histopathological evaluation of colon HE-stained specimens for ulcerative colitis in mice. However, both examples, does not even link shown data to the claimed treating Crohn’s disease.
So, the provided data is very limited. Accordingly, applicants failed to describe actual reduction to practice of the claimed invention.
(B) If the application does not describe an actual reduction to practice, determine whether the invention is complete as evidenced by a reduction to drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole:
Brief Description of Drawings are limited to FIG. 1, which shows the histological score results in Example 2.
No drawings are provided to prove that the shown data can be extrapolated to treat Crohn’s disease.
(C) If the application does not describe an actual reduction to practice or reduction to drawings or structural chemical formula as discussed above, determine whether the invention has been set forth in terms of distinguishing identifying characteristics, such as structure/function correlations, as evidenced by other descriptions of the invention that are sufficiently detailed to show that applicant was in possession of the claimed invention:
Both Crohn’s disease and ulcerative disease are inflammatory bowel diseases, but they differ in the depth of inflammation and location/pattern. Crohn’s can be anywhere in the body, such as mouth, small/large intestine etc., whereas ulcerative colitis can be seen only in the large intestine, always starting at the rectum and moving up continuously. Depth of inflammation in Crohn’s is transmural, i.e., affects all layers of the bowel wall, whereas ulcerative colitis is limited to the inner most lining (mucosa).
So far as the examiner is aware, applicants’ SEQ ID NO:1 has not been successfully used for treating Crohn’s disease. However, SEQ ID NO:1 is known to treat ulcers, as evidenced from the teachings of Ellis-Behnke (US 2008/0032934 A1) or Kobayashi (US 9,724,448 B2) etc. Although the state of the art is relatively high with regard to the treatment of Crohn’s disease, but the state of the art with regard to recited sequence, for treating Crohn’s disease are not well established in the art.
In view of above, there are no physical/chemical/structural features that applicants have tied to the claimed method in light of shown data, making it impossible for an individual of ordinary skill in the art to envision the claimed method. Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement.
Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claimed subject matter and does not reasonably convey to one skilled in the relevant art that the inventors had possession of the entire scope of the claimed invention.
Nonstatutory Double Patenting Rejection
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.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US copending patent application number 18/661,641.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
For claims 1-3:
Claims 22-23 of copending application teach a method of treating or preventing a refractory ulcer in the intestinal tract by administering SEQ ID NO:1, wherein ulcer in the intestinal tract is caused by ulcerative colitis or Crohn’s disease etc.
For claim 4:
Claims 24 of copending application teaches, the composition is locally applied to an ulcer site using an endoscope and an anoscope.
For claims 5-6:
Claim 26 of copending application teaches composition further comprises additional drug to treat an ulcer in the intestinal tract. Though claims are silent on name of drug, but it is obvous to use known drug for treating the recited condition.
The difference, however, does not constitute a patentable distinct, because claims of copending application are broader in scope. However, claims of instant application fall within the scope of copending application. Since the scope overlaps, and species are narrow, and so, the claims are obvious over the claims of copending application.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not been patented yet.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/ Primary Examiner, Art Unit 1658