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 .
Election/Restrictions
Claims 10-18 are newly added by the present amendment. Newly submitted claims 14-18 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be used in a materially different process since the product is not bound by the claimed intended use.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 14-18 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
Response to Remarks/Amendments
Applicant’s amendments filed November 28, 2025 have been entered. All rejections and objections not explicitly maintained herein are withdrawn in view of the claim amendments. The rejections below constitute the full set of rejections being applied to the instant claims.
With regard to the rejection under 35 USC 102(a)(1), Applicant traverses the rejection on the grounds that Ahad has not directly disclosed or substantiated the medicinal use of Goji berries, or its component N1-dihydrocaffeoyl-N10-caffeoylspermidine. However, as noted in the Claim Interpretation section of the previous Office action (and reiterated herein), the recitation "drug" does not add any structural limitation to the claimed composition in addition to the structural features required by the recitation of the compositions themselves. Accordingly, since the body of the claims fully and intrinsically sets forth all of the limitations of the claimed invention (the claimed compound) 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 compositions and is not significant to the claim construction, as per MPEP 2111.02(II).
With regard to Applicant’s description of drugs having a “primary purse to prevent, diagnose, and treat diseases,” it is noted that the purpose or intention of a composition is not considered a limitation as described above, since intended use is not significant to the claim construction of a product claim. Applicants further argue that medications have relatively simple compositions or clearly defined primary components, require precise dosing, and require regulation and approval. As noted in the previous Office action and reiterated herein, the only structural feature required by the instant claims is the presence of the compound N1-dihydrocaffeoyl-N10-caffeoylspermidine.
Applicant finally argues that the instant specification describes that the claimed compound “can be obtained through commercial or experimental preparation.” In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., how the compound is obtained) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). However, it is noted that even if the limitations from the specification were imported into the claims, they would be interpreted as product-by-process limitations and not limiting to the claim construction, since the compound itself is structurally the same regardless of how it is prepared.
Status of Claims
Currently, claims 6-7 and 10-18 are pending in the instant application. Claims 14-18 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 6-7 and 10-13 read on an elected invention 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 Interpretation
As an initial matter, the Examiner would like to provide an interpretation of the claimed “drug for preventing and treating insomnia, anxiety and depression.” Notably, the only structural features actually required by the claim is the presence of the compound N1-dihydrocaffeoyl-N10-caffeoylspermidine. Similarly, the recitation of the drug “wherein a single application dose is…” is interpreted as being directed to an intended use of applying the drug.
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 "drug" does not add any structural limitation to the claimed composition in addition to the structural features required by the recitation of the compositions themselves. Accordingly, since the body of the claims fully and intrinsically sets forth all of the limitations of the claimed invention (the claimed compound) 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 compositions 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) 6-7 and 10-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ahad et al.
The prior art teaches Lycium barbarum fruit (Goji berry) as a traditional Chinese medicine having outstanding biological and pharmacological activities, as well as the separation and chemical profiling of spermidine alkaloids contained within the fruit (see Abstract). As evidenced by Ahad, the fruit contains the instantly claimed compound, which is described as compound S2 (Fig. 1):
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. Given the evidence that the compound is contained within the fruit, the fruit itself reads on the claimed drug (see section 2.2, referencing dried goji berry fruit), given that the only required feature of the claimed invention is the compound itself.
Since the prior art teaches all required features of the instantly claimed invention, 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.
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.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699