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 Claims and Response to Amendments
The amendments filed August 14, 2025 have been acknowledged and entered. Claim 1 is pending.
Election/Restriction
The present examination is based on Applicant’s election of Formula (I) (pictured below) in the response filed December 31, 2024 and April 9, 2025. Applicant remarks filed August 14, 2025 did not overcome the art rejection set forth in the previous office action. The search has thus been limited to the elected species. See MPEP § 803.02.
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Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this Office Action has been withdrawn or rendered moot in view of Applicant’s amendments and/or
remarks.
Maintained Rejections
Claim Rejections - 35 USC § 112a
Claim 1 is 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 method of treating pancreatitis, arthritis, or hepatitis comprising administering a compound of Formula (I) wherein X and Y are each N, does not reasonably provide enablement for preventing pancreatitis, arthritis, or hepatitis comprising administering a compound of Formula (I). 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. When a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation. See In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991) (claiming a chimeric gene capable of being expressed in any cyanobacterium and thus defining the claimed gene by its use).
The reasons for this rejection were set forth in the previous Office Action mailed May 14, 2025 and are incorporated herein by reference.
Response to Arguments
Applicant’s arguments filed August 14, 2025 have been fully considered but they are not persuasive.
Applicant states they have amended claim 1 to be specific to the treatment and prevention of pancreatitis, arthritis, and hepatitis, and therefore respectfully requests withdrawal of the rejection (Applicant remarks, Claims Rejections under 35 USC 112(a)).
The amendments do not overcome the rejection because the claims still recite “prevention”. Moreover, Applicant’s remarks do not address the rejection over “prevention” which was set forth previously.
The rejection is still deemed proper and thus maintained.
Claim Rejections - 35 USC § 112b
Claim 1 is 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. The claim is indefinite for the reasons that follow:
Claim 1 recites the limitation “for preventing and treating” which is an intended uses of the claimed compound that does not appear to impart any structural limitation to the claimed compound and therefore does not limit the claim. The intended use limitations should be deleted or the claims should be amended to recite a method of use.
Claim 1 has been amended to delete “ester group” and instead recite “ester”. The limitation “ester” is unclear because this is a class of compounds. If it is derived from a carboxylic acid, it’s the compound R-C(O)-O-R.” The group R-C(O)-O- would be alkanoyloxy and the group -C(O)-O-R” would be alkoxycarbonyl, assuming R and R” are alkyl groups. Applicant has provided no definition of which “esters” are included in the scope of the claim or the connectivity to the alkyl.
Response to Arguments
Applicant’s arguments filed August 14, 2025 have been fully considered but they are not persuasive.
Applicant states they have amended claim 1 per the Office’s suggestion and therefore requests withdrawal of the rejection (see Applicant remarks, Claim Rejections under 35 USC 112(b)). The amendment does not overcome the rejection because the claim still recites intended uses which do not limit the structure of the claimed compound.
MPEP 2111.02, II, Preamble Statements Reciting Purpose or Intended Use provides the following guidance:
The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "‘extraneous’ limitations from the specification." Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. 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);
In the present case, Applicant’s invention is a compound and all structural limitations of the compound are set forth in the body of the claim. The intended uses are thus not considered to limit the structure of the invention.
As per “ester”, the limitation “ester” can correspond to many different structures and so one skilled in the art cannot say which “esters” are included in the scope of the claim. The metes and bounds of the invention are therefore unclear. The rejections are is still deemed proper and maintained. Appropriate clarification is still required.
Claim Rejections - 35 USC § 102
Claims 1 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chemical Abstract Services STNext (Registry Number 1222828-39-8; entered May 2010)(hereinafter “CAS STN”).
Examiner notes that Applicant has amended claim 1 to delete the limitations X and Y. However, the specification teaches at [0010] that X and Y can be C or N. The scope of the claims are therefore regarded as including the compound of CAS STN as set forth previously and repeated below.
CAS STN teaches the instantly elected species which corresponds to Formula (I) wherein X and Y are each N; R1 is a C2alkyl substituted with an ester (e.g.
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); R2 and R5 are each O; and R3 and R4 are each C1 alkyl (See pages 144-145 of the STN search provided with this office action)
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The reasons for this rejection were set forth in the previous Office Action mailed May 14, 2025 and are incorporated herein by reference.
Response to Arguments
Applicant’s arguments filed August 14, 2025 have been fully considered but they are not persuasive.
Applicant argues here, the Examiner simply refers to the registration of the compound in the Chemical Abstract Services STNext registry to support the reliance on inherency. Nothing is offered suggesting that the use of the compound to treat and prevent pancreatitis, arthritis, and hepatitis is present or a natural result of the prior art. Applicant further argues that the anticipation rejection relying on the theory of inherency is improper (Applicant remarks, Claim Rejections under 35 USC 102).
In response to these arguments, Examiner respectfully points out that the claimed invention is a compound for which all the structural limitations are provided in the body of the claim. The intended uses “for preventing or treating inflammation…” are recited in the preamble of the claim, do not impart any structural limitation to the invention, and therefore do not limit the claim. Because the prior teaches all structural limitations of Applicant’s invention, it necessarily follows that the prior art structure will inherently have the same properties or biological activities or be capable of performing the same intended uses and those recited in the claim. Moreover, “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference” See MPEP 2112. In the present case, the inherency logically flows from the fact that the structure of the compound in the prior art and instant claims are identical. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.
The rejection is still deemed proper and thus maintained. Examiner further notes that a novel and nonobvious method of using a prior art compound or composition is patentable.
Rejections Necessitated by Applicant Amendment
Claim Rejections - 35 USC § 112b
The following is a quotation of 35 U.S.C. 112(b):
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 is 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. The claims are indefinite for the reasons that follow:
Claim 1 recites variables X and Y (see Formula I); however, the claim does not provide any definition of X or Y. The claim should be amended to include the definitions of X and Y so as to clearly outline the metes and bounds of the invention.
Conclusion
No claim is 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 KEVIN MARTIN whose telephone number is (571)270-0917. The examiner can normally be reached Monday - Friday 8 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached on (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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August 26, 2025
/K.S.M./Examiner, Art Unit 1624
/BRUCK KIFLE/Primary Examiner, Art Unit 1624