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
This office action is in response to applicant’s reply filed on October 6, 2025.
Restrictions/Elections.
Applicant’s election without traverse of Group II (Claims 2 and 4-19) in the reply filed on October 6, 2025, is acknowledged.
Applicant election of the following species:
1-
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as the compound of formula (I), and
2- Bacterial infection, wherein the bacteria are bacillus spizizenii and/or Staphylococcus aureus,
Is also acknowledged.
Status of Claims
Claims 2 and 4-19 are currently pending and are the subject of this office action.
The following claims are withdrawn because they do not encompass the elected species: bacterial infection wherein the bacteria are bacillus spizizenii and/or Staphylococcus aureus: claims 7-16.
Claims 2, 4-6 and 17-19 are presently under examination,
The following species are under examination:
1-
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as the compound of formula (I), and
2- Bacterial infection, wherein the bacteria are bacillus spizizenii and/or Staphylococcus aureus,
Priority
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Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1) Claim(s) 2, 4-6, 17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klink et. al. (Journal of Medical Microbiology (2003) 52: 303-308, cited by Applicant), Av-Gay et. al. (US 2015/0132345), Handa et. al. (US 2019/0358368), Schoenfisch et. al. (US 2021/0346424) in view of Nilsson et. al. (Drug Design Development and Therapy (2018) 12:685-694) and in view of Gustafsson et. al. (WO 2007/106034, cite by Applicant).
For claims 2, 4-6 and 17, Klink teaches that Nitric Oxide (NO) donors like nitroprusside or 3-morpholinosydnonimine are effective in treating bacterial infection in humans (see title, abstract and page 305 under: Effect of NO donors on the survival of bacteria).
Av-Gay teaches NO-releasing (i.e. NO-donors) agents are effective in killing a wide range of bacteria, viruses, fungi and yeasts associated with skin infections (see [0008]). Gel formulations containing NO-donors have been demonstrated to possess antibacterial activity against E. coli, C-P. aeruginosa, B. subitilis and S. aureus as well as significant anti-inflammatory activity (see [0008]).
Handa teaches NO-releasing agents, like S-nitrosothiols and N-diazeniumdiolates, are effective in treating bacterial infections (see [0037] and [0070]). Among the bacteria they mention Staphylococcus aureus (see [0030]).
Schoenfisch teaches that several chronic infections are caused by biofilm-forming pathogens like Pseudomonas aeruginosa and Staphylococcus aureus. They disclose NO-releasing cyclodextrins that are effective in treating biofilm-forming bacteria like Staphylococcus aureus (see [0006], [0107], [0173], [0469], [0472]-[0473], [0476] and [0481]).
In summary, the prior art teaches that NO-releasing agents, regardless of their structure, are effective in treating bacterial infections.
The prior art does not teach the treatment of bacterial infection with the instantly claimed compounds like:
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.
However, Nilsson teaches (see title and abstract) that mononitrites of 1,2-propanediol (PDNO) like compound (1) (see Figure 1 on page 686):
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are NO-releasing agents that are effective in treating NO-related diseases like pulmonary hypertension.
Finally, Gustafsson teaches “a method for the manufacture of a medicament for the treatment of a condition where NO has a beneficial effect, wherein a compound obtainable through a method to any of claims 1-29, is administered to a patient with said condition” (see claim 40), wherein the compound can be the NO-donor compound I (see page 5):
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Further, Gustafsson teaches that the instant compounds have less side effects than previously known NO-donors (see background from pages 1 through 5).
Since the prior art teaches a method of treating bacterial infections in general and Staphylococcus aureus in particular comprising the administration of a structurally diverse set of NO-donors, and since the prior art teaches that compounds like 2-hydroxy-propyl nitrite:
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are NO-donors that can effectively be used in any a condition where NO has a beneficial effect, before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to substitute one functional equivalence (any NO-donor) for another (2-hydroxy-propyl nitrite) with an expectation of success, since the prior art establishes that both function in similar manner. The skilled in the art will be further motivated to replace previously known NO-donors with 2-hydroxy-propyl nitrite, since this NO-donor is less toxic.
All this will result in the practice of claims 2, 4-6 and 17, with a reasonable expectation of success.
For claim 19, the prior art does not explicitly teach that the treatment reduces or inhibits replication of the bacteria. However, it is inherent that reduction of the bacteria will occur in such treatment since according to the prior art NO gas is toxic to bacteria.
Further, the statement in claim 19: “wherein the treatment reduces or inhibits replication of the bacteria” does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “a method for treating bacterial infections comprising the administration of a patient in need thereof a composition comprising a compound of formula (I) like 2-hydroxy-propyl nitrite".
MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “wherein the treatment reduces or inhibits replication of the bacteria” appears to be the result of the process made obvious by the prior art: “a method for treating bacterial infections comprising the administration of a patient in need thereof a composition comprising a compound of formula (I) like 2-hydroxy-propyl nitrite ", e. g. the intended result of a process step positively recited. As such, this limitation in the instantly claimed method has not been given any weight.
All this will result in the practice of claim 19 with a reasonable expectation of success.
2) Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klink et. al. (Journal of Medical Microbiology (2003) 52: 303-308, cited by Applicant), Av-Gay et. al. (US 2015/0132345), Handa et. al. (US 2019/0358368), Schoenfisch et. al. (US 2021/0346424) in view of Nilsson et. al. (Drug Design Development and Therapy (2018) 12:685-694, cited by Applicant) and in view of Gustafsson et. al. (WO 2007/106034, cite by Applicant), as applied for claims 2, 4-6, 17 and 19, further in view of David (US 2005/0108047).
The prior art teaches all the limitations of claim 18, except for the symptoms of the infected patient being fever or pain. However, David teaches that symptoms bacterial infections are pain and fever (see [0086]), thus resulting in the practice of claim 18 with a reasonable expectation of success.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
October 14, 2025.