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 .
Status of the Application
The amendment and remarks of 30 September 2025 are entered.
Claims 1-29 are pending. Claim 29 is withdrawn with traverse. Claims 1-28 are being examined on the merits.
Applicants’ entry into the PPH program as of 28 May 2025 is acknowledged.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-28) in the reply filed on 30 September 2025 is acknowledged. The traversal is on the ground(s) that the cited art requires administration with a copper salt/complex and/or a zinc salt/complex and/or a iron salt/complex. The Applicants argue this is different from the approach of the instant application for achieving absorption. The Applicants argue without the salts/complexes there would not be high bioavailability. The Applicants argue copper or salts are not allowed in nasal drug products. The Applicants argue a teaching away by Werle. This is not found persuasive because nothing in the claims limits the composition to one not having a copper, zinc, or iron salt/complex, especially given the open-ended “comprising” transitional phrase of the claimed invention. A different approach by Werle is unpersuasive since Werle still discusses use of permeation enhancers. High bioavailability is not a claim limitation. Finally as to copper or salts not being permissible in nasal drug formulations and thus a teaching away, as discussed below the intranasal administration and use is treated as an intended use that is not of significance to claim construction, and as such does not constitute a limitation that is taught away from by Werle.
The requirement is still deemed proper and is therefore made FINAL.
Claim 29 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 30 September 2025.
Claim Interpretation
Claim 1 recites in the preamble the statement that the composition is “for intranasal administration for treatment or prevention of diabetes mellitus, obesity, nonalcoholic fatty liver disease (NAFLD), or neurodegenerative diseases”. Per MPEP 2111.02 II., statements reciting an intended use are read in context of the claim. Furthermore, MPEP 2111.02 II. notes:
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. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also 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"); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that the preamble phrase "which provides improved playing and handling characteristics" in a claim drawn to a head for a lacrosse stick was not a claim limitation). Compare Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333-34, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003) (In a claim directed to a method of treating or preventing pernicious anemia in humans by administering a certain vitamin preparation to "a human in need thereof," the court held that the preamble is not merely a statement of effect that may or may not be desired or appreciated, but rather is a statement of the intentional purpose for which the method must be performed. Thus the claim is properly interpreted to mean that the vitamin preparation must be administered to a human with a recognized need to treat or prevent pernicious anemia.); Nantkwest , Inc. v. Lee, 686 Fed. App'x 864, 867 (Fed. Cir. 2017) (nonprecedential) (The court found that the preamble phrase "treating a cancer" "’require[s] lysis of many cells, in order to accomplish the goal of treating cancer’ and not merely lysing one or a few cancer cells."); In re Cruciferous Sprout Litig., 301 F.3d 1343, 1346-48, 64 USPQ2d 1202, 1204-05 (Fed. Cir. 2002) (A claim at issue was directed to a method of preparing a food rich in glucosinolates wherein cruciferous sprouts are harvested prior to the 2-leaf stage. The court held that the preamble phrase "rich in glucosinolates" helps define the claimed invention, as evidenced by the specification and prosecution history, and thus is a limitation of the claim (although the claim was anticipated by prior art that produced sprouts inherently "rich in glucosinolates")).
In this case, the preamble statement referencing intranasal administration and treatment or prevention of diabetes mellitus, obesity, NAFLD, or neurodegenerative disease is interpreted as reflecting an intended use of the pharmaceutical composition and is not considered to be of significance to claim construction. Therefore, the claim is interpreted to be drawn to a pharmaceutical composition comprising an active ingredient comprising 0.01%-20% w/v of semaglutide, essential excipients, and further comprising one or more penetration enhancers selected from a cell penetrating peptide, tight junction modulating agent, or bioadhesive agent.
Claim Objections
Claims 7 and 13 are objected to because of the following informalities: poloxamer is misspelled as “poloxmer”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a pharmaceutical composition for intranasal administration for treatment of diabetes mellitus, obesity, NAFLD and neurodegenerative diseases, does not reasonably provide enablement for a pharmaceutical composition for intranasal administration for prevention of diabetes mellitus, obesity, NAFLD and neurodegenerative diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims..
“[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997); In re Wright 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); See also Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed. Cir. 1991); In re Fisher 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). Further, in In re Wands 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) the court stated:
Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman [230 USPQ 546, 547 (BdPatAppInt 1986)]. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredict-ability of the art, and (8) the breadth of the claims.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Nature of the Invention
The invention is drawn to a pharmaceutical composition for intranasal administration for treatment or prevention of diabetes mellitus, obesity, NAFLD and neurodegenerative diseases. The composition contains semaglutide and a permeation enhancer.
Breadth of the Claims
The claims are broad with respect to encompassing both treatment and prevention of a variety of diseases. Neurodegenerative diseases in particular encompass a wide variety of conditions.
State of the Prior Art
The prior art recognizes that neurodegenerative diseases are not a single condition but encompasses several types of disorders (see e.g. https://my.clevelandclinic.org/health/diseases/24976-neurodegenerative-diseases). Among the disorders encompassing neurodegenerative diseases includes dementia-type diseases, demyelinating diseases, Parkinsonism-type diseases, motor neuron diseases, and prion diseases (see e.g. Type of this condition section). The Cleveland Clinic art also notes that neurodegenerative diseases are permanent and incurable, which also implies that they cannot be prevented.
The art additionally does not recognize preventative compositions for diabetes mellitus, obesity, and NAFLD.
Relative Skill of those in the Art
The relative skill of those in the art is high.
Predictability or Unpredictability of the Art
There is a general lack of predictability in the pharmaceutical art. In re Fisher, 427, F. 2d 833, 166, USPQ 18 (CCPA 1970).
Amount of Direction or Guidance Given
The specification offers no guidance on prevention of any of the claimed conditions. The Examiner cannot identify any instance where preventing or prevention occurs in the specification as filed.
Presence/Absence of Working Examples
There are no examples of prevention of any of the claimed conditions.
Quantity of Experimentation Necessary
The onus is placed on the skilled artisan to determine if the compositions across the range as claimed are both able to be administered intranasally and prevent diabetes mellitus, obesity, NAFLD, and neurodegenerative diseases. As noted above, the art already recognizes that neurodegenerative diseases are permanent and incurable, i.e. prevention is not a possibly. There is no recognized preventative measure for any of the other claimed conditions. Therefore, the skilled artisan is left with an undue burden to essentially prove that the compounds as claimed are a first preventative treatment for a wide range of conditions. While it is undisputed that semaglutide can treat conditions such as obesity and diabetes mellitus, there is currently no evidence that it is a preventative measure for the claimed conditions. Since all clinical testing is left on the part of the skilled artisan for the compositions as claimed, the experimentation and burden is undue.
In view of the Wands factors as discussed above, it is the Examiner’s opinion that the claims are not fully enabled and one of skill in the art would have to engage in undue experimentation to practice the invention as claimed herein, without a reasonable assurance of success.
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.
Claims 1-28 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.
Regarding claim 1, the term “essential excipient” is indefinite because the metes and bounds associated with “essential” is not clear. The specification does not define the terminology, and the art does not recognize a specific class of “essential excipients” that might lead one of ordinary skill in the art to understand what may or may not read upon the claims as written. The dependent claims do not remedy this deficiency.
Claims 7 and 14 contain the trademark/trade name CARBOPOL. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a particular bioadhesive agent and, accordingly, the identification/description is indefinite.
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 (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.
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.
1. Claims 1 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Laine et al. (WO 2020/234384 A1, published 26 November 2020, hereafter referred to as ‘384).
As noted above, the “for intranasal administration for treatment or preventing of diabetes mellitus, obesity, nonalcoholic fatty liver disease (NAFLD), or neurodegenerative diseases” clause is treated as an intended use of the composition that is not of significance to claim construction per MPEP 2111.02. The claim is interpreted accordingly as being drawn to a pharmaceutical composition comprising semaglutide at 0.01-20% w/v, an excipient, and a permeation enhancer selected from cell penetrating peptides, tight junction modulating agents, or bioadhesive agents.
The ‘384 application claims a composition containing semaglutide, a sodium glucose co-transporter 2 inhibitor, and a cyclodextrin (see e.g. claims 1, 3, and 4). The semaglutide is claimed as being a about 0.5 mg/ml, which is 0.05% by weight (see e.g. claim 8). This anticipates claim 1.
With respect to claim 25, this language merely restricts the intranasal administration route, which as set forth is not considered to be of significance to claim construction. Accordingly, the intranasal administration route is not found to be of significance to claim construction, such that the claim is still drawn to a pharmaceutical composition comprising semaglutide and a permeation enhancer.
2. Claims 1, 25, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Werle M and Foger F (WO 2019/193204 A1, published 10 October 2019, hereafter referred to as ‘204).
The ‘204 application claims a composition for transmucosal administration comprising a peptide drug (see e.g. claim 1). The composition further contains an excipient (see e.g. claims 5-7). The peptide drug can be semaglutide and further include a permeation enhancer (see e.g. claims 11 and 12). The permeation enhancer includes a wide variety of options including penetratin (see e.g. claims 13 and 14). While not considered to be of significance to claim construction, notably ‘204 discusses nasal delivery (see e.g. claim 24). Specific examples suggest 50 mg/ml semaglutide and the ’204 application guides that dosages can be adjusted as needed (see e.g. p.31 lines 4-11 and Example 18). Therefore, ‘204 anticipates claim 1.
With respect to claim 25, this language merely restricts the intranasal administration route, which as set forth is not considered to be of significance to claim construction. Accordingly, the intranasal administration route is not found to be of significance to claim construction, such that the claim is still drawn to a pharmaceutical composition comprising semaglutide and a permeation enhancer.
With respect to claim 28, ‘204 suggests a suspension or emulsion (se e.g. p.22).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY J MIKNIS whose telephone number is (571)272-7008. The examiner can normally be reached M-F 9-5.
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/ZACHARY J MIKNIS/Patent Examiner, Art Unit 1658