DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application is a 35 USC 371 National Stage entry of international application PCT/IB2022/056066, filed June 29, 2022, which claims priority under 35 USC 119(a)-(d) from European application EP 21182587.2, filed June 29, 2021.
Information Disclosure Statement
The information disclosure statement dated May 30, 2024 was in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the IDS document was considered and signed copies of the 1449 forms are attached.
Election/Restrictions
Applicant’s election with traverse of the invention of Group I, claims 1-12 and 16-19, in the reply filed April 15, 2026 is acknowledged. Further, Applicant’s election of the species of Compound
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in the same reply is also acknowledged. The elected species reads on each of claims 1-12 and 16-19 within the elected group.
The traversal is on the grounds that no unity of invention objection was made in the international application, so there should be no unity of invention objection or restriction requirement in the instant application. This traversal has been considered but is not found to be persuasive because the United States Patent and Trademark Office is not bound by the lack of unity determination by another International Searching Authority. MPEP 1875 states that whether or not the question of unity of invention has been raised by the International Searching Authority, it may be considered by the examiner when serving as an authorized officer of the International Preliminary Examining Authority. Thus, the examiner is not bound by any previous determination made. In addition, 37 CFR 1.484 indicates that the international preliminary examination is a non-binding opinion. Finally, 37 CFR 1.499 states that if the examiner finds that a national stage application lacks unity of invention under 37 CFR 1.475, the examiner may in an Office action require the applicant, in response to that action, to elect the invention to which the claims shall be restricted. Thus, the determination of lack of unity is proper for the reasons above and those set forward in the requirement.
Applicants further traverse on the grounds that searching all claims together would not impose a serious burden. Regarding this traversal, it is noted that the restriction was required under lack of unity rather than US practice. As such, the Examiner is not required to establish search burden to properly restrict between groups, but only to demonstrate that the groups lack unity, which was done properly. As set forth in the restriction requirement, the groups are lacking unity because there the only shared feature among the claims of the two groups is known in the art as described herein. However, even if the establishing of search burden were required, the arguments would still not be persuasive. In establishing search burden, the following criteria have been established by the Office:
There would be a serious search and examination burden if restriction were not required because one or more of the following reasons apply:
the inventions have acquired a separate status in the art in view of their different classification;
the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);
the prior art applicable to one invention would not likely be applicable to another invention;
the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112(a).
In the instant case, the prior art applicable to one invention would not necessarily be applicable to another invention since the steps required by the method of use claims are not required limitations of the claimed products.
The restriction (lack of unity) requirement is still deemed proper and is therefore made FINAL.
In accordance with the MPEP, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species and the claims drawn to the elected species are allowable, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As indicated above, the Examiner searched the claimed invention based on the elected species above, wherein: the claims to the elected species were not found to be free of the prior art. However, additional compounds discovered incidental to the elected species are also included in the rejections herein to promote compact prosecution. As such, in accordance with MPEP 803.02, the scope of the search and consideration was not extended beyond the elected species.
Status of Claims
Currently, claims 1-22 are pending in the instant application. Claims 13-15 and 20-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim.
Claims 1-12 and 16-19 read on an elected invention and species and are therefore under consideration in the instant application to the extent that they read on the elected embodiment and extended scope indicated above. Subject matter falling under the scope of a non-elected invention II, as well as the other non-elected species encompassed by the elected invention, are currently withdrawn from examination.
Claim Objections
Claim 12 is objected to for depending on a rejected base claim.
Claim Interpretation
As an initial matter, the Examiner would like to provide an interpretation of the claimed “enteral or urinary pharmaceutical formulation” and other similar language. Notably, the only structural feature actually required by the claimed composition is the presence of a compound of formula (I) and either a pharmaceutically acceptable excipient or another therapeutic agent.
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. 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.); 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 the present case, the recitation of "enteral or urinary pharmaceutical composition," “for delivery in the ileum or colon,” “for enteral administration,” “for enteral administration through a delayed release formulation,” does not add any structural limitation to the claimed composition beyond the structural features required by the recitation of the components themselves. Accordingly, since the body of the claims fully and intrinsically sets forth all of the limitations of the claimed invention and the recitations noted above do not add any additional structural feature to the claimed product, this statement in the preamble is interpreted as an intended use of the claimed media and is not significant to the claim construction, as per MPEP 2111.02(II).
Claim Rejections – 35 USC § 102
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.
Claim(s) 1-11 and 16-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2006/029818 (“the ‘918 publication”).
The prior art teaches cosmetic compositions of the compound
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for treating or preventing any symptoms caused by negative developments of physiological homeostasis of healthy skin and a cosmetic carrier (Abstract). In particular, the compounds N-hydroxy-2-octenamide
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and the instantly elected species N-hydroxyactinamide
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are both exemplified by the prior art (p. 5). The ‘918 publication teaches that compositions of the compounds taught therein can also contain usual cosmetic or pharmaceutical adjuvants and additives, such as preservatives/antioxidants, fatty substances/oils, water, organic solvents, silicones, thickeners, softeners, emulsifiers, sunscreens, antifoaming agents, moisturizers, fragrances, surfactants, fillers, sequestering agents, anionic, cationic, non-ionic or amphoteric polymers or mixtures thereof, propellants, acidifying or basifying agents, dyes, colorants, pigments or nanopigments, e.g. those suited for providing a photo-protective effect by physically blocking out ultraviolet radiation, or any other ingredients usually formulated into cosmetics or medicaments (p. 7, ll. 13-20). Accordingly, the ‘918 publication teaches all the required elements of the instantly claimed composition and the claims are anticipated.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699
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