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
Applicant's election with traverse of Group 1 (Claims 1-4) in the reply filed on 5/11/2026 is acknowledged. The traversal is on the ground(s) that the invention are not patentably distinct because they utilize the exact same mode of action and methodology and involves the same dosages and concentrations relative to the body weight for both subjects. This is not found persuasive because while they may involve the same asserted mode of action, the “patient” population appear to be different in that Group I involves livestock and Group II involves treating coronavirus in human.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-9 are currently pending.
Claims 5-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 5/11/2026.
Claims 1-4 are currently under consideration.
Drawings
The drawings are objected to because at least Fig 1A-Fig. 1C are ineligible and/or appear to be in a foreign language. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-4 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The criteria for enablement set out in the In re Wands, MPEP 2164.01(a), considers the following factors:
Breadth of the Claims
The instant claims are directed toward a method of strengthening livestock so as to prevent the livestock from becoming diseased and/or fight off disease of the livestock, comprising: feeding the livestock with animal feed or drinking water, wherein the animal feed or drinking water is supplemented with an additive comprising a solution of benzaldehyde in water, the benzaldehyde constitutes at least 0.1% by volume of the solution. Thus, the claims imply ingestion or in vivo administration (oral) of at least 0.1% by volume of benzaldehyde in water, wherein benzaldehyde is the active agent in vivo and is responsible for the prevention of the livestock from becoming diseased or fighting off the disease in the livestock.
Thus, the breadth of the claims is great.
Level of Skill in Art
The level of skill in the art is a clinician or an artisan with a PhD.
Working Examples
The specification teaches that as a result of the addition of benzaldehyde solution to the animal feed, it is no longer necessary to add antibotics since the benzaldehyde solution is highly antibiotic and antiviral (page 7, 2nd full paragraph). The specification further provides Example 1 referred to as “A Laboratory Study on Fish”:
As shown in FIG. 1A, FIG. 1B, FIG. 1C, under laboratory conditions performed by the Institute for Food Microbiology in Israel during August through September 2020, a solution of formaldehyde in water (5% by volume) was poured on large fish called tilapia (the English translation of the fish that in Hebrew is called Amnoon), a freshwater fish that feeds on plant life. The fish were divided into four groups labeled “T”, “T1”, “T2” and “T3”. A corresponding amount (by weight) offish was divided into four control group and was labeled as “S”, “S1”, “S2” and “S3”. “T1”, “T2” and “T3”. Were treated with the 5% benzaldehyde solution in water. “S” and “T” were similarly treated with the benzaldehyde solution but in ice water (the benzaldehyde solution had been placed in the freezer).
The amount of specific bacteria was measured for each group of fish at three times (both with the treated group and the control group at the same time). The three times are: after 10 minutes (FIG. 1A), after 5 days of continuous treatment (FIG. 1B) and after 12 days of continuous treatment (FIG. 1C). In each case, the total bacterial count was also measured and the results appear in specific columns depending on the specific bacteria (Listeria spp., Salmonella ISO, E. coli count, Sulfite reducing clostridia count, Staphylococcus aureus count, Coliforms count, total count). The results appear in FIGS. 1A-1C.
The results show that the treated groups of fish showed marked reduction in bacteria levels. For example, following a period of 12 days from fishing to test and application of the benzaldehyde 5% preservative solution, the following results were obtained: The total count for the treated fish was 140. The total count for the control group was 29,250. For the Coliforms (measured in CFU/G) the results were <10 for the treated group and 5,400 for the control group.
The results showed a very significant reduction in bacteria for fish that were treated with the solution of benzaldehyde 5% compared to the control group.
Direction and Guidance
Example 1, as it relates to the instantly claimed invention provides minimal direction. For example, it is unclear the impact of the initial treatment with formaldehyde since formaldehyde is a known antibacterial agent (see for example, Nikolic et al. (MicrobiologyOpen 2020: e1054) and was not used on the control group. Moreover, while the examiner recognizes that water would be considered drinking water for fish, it is unclear how much of the 5% solution in water was added and what the volume of water was. Lastly, it is unclear whether the bacteria levels are being measured within the fish or within the water.
Quantity of Experimentation
In view of the unpredictability of the art in treating fragile X syndrome, and the lack of direction in the specification, the amount of experimentation required to determine which GABA(A) alpha 2 and/or 3, agonist or partial agents prevent which one or more signs or symptoms of fragile X syndrome, would be astronomical. For each sign or symptom and each GABA(A) alpha 2 and/or 3 agonist or partial agonist, a great deal of experimentation would be required starting with proof-of-concept, and proceeding through all levels of lead identification and optimization, This amounts to invention, not development; it is an undue amount of experimentation.
State of the Prior Art/Predictability of the Prior art
The state of the prior art at the time of filing recognized that benzaldehyde has been used in in cosmetics as a denaturant, a flavoring agent and as a fragrance and is generally regarded as safe food additive in the United States and is accepted as a flavoring substance in the European Union (see 2006-Final Report on the Safety Assessment of Benzaldehyde (International Journal of Toxicology, 2006; 25(Supp.1): 11-27). In addition to its use in cosmetics and as a food additive, benzaldehyde has also been shown to contain antimicrobial properties. For example, Bowles and Juneja (Journal of Food Safety 1998; 18: 101-112) demonstrated that benzaldehyde has antimicrobial properties in several common foodborne bacteria including E. Coli, Staphylococcus aures and Clostridium botulinum. Similarly, Ullah et al. (Journal of Microbiology 2015; 53(2): 127-133) evaluated the antimicrobial activity of benzaldehyde in several lines of bacteria and fungi and found that benzaldehyde killed 72-80% at the minimum inhibitor concentration (page 132, 1st column, 1st full paragraph). In addition to benzaldehyde alone, Roberts, Donald (US20170223969A1, 2017-08-10) teach antibacterial compounds and compositions obtained from plants in the Rosaceae, genus Prunus, wherein the compounds within the compositions include, but are not limited to, benzaldehyde (paragraph 0006). The PGPub further provides the in vitro inhibitory effects on several microorganisms with a proprietary formulation collected from Prunus plants, but is silent on the components of the formulation (See example 1).
Thus, the while the prior art teaches that it is known in the art that benzaldehyde is an effective antimicrobial to numerous bacteria in vitro, the prior art is silent regarding the in vivo inhibitory effect of benzaldehyde to prevent livestock from becoming diseased and/or fight off disease of the livestock.
Therefore, in view of the lack of guidance in the specification, lack of clarity within the working examples, the state of the art and lack of predictability in the art, the instant claims drawn to a method of strengthening livestock so as to prevent the livestock from becoming diseased and/or fight off disease of the livestock, comprising: feeding the livestock with animal feed or drinking water, wherein the animal feed or drinking water is supplemented with an additive comprising a solution of benzaldehyde in water, the benzaldehyde constitutes at least 0.1% by volume of the solution is not enabled.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1-2, 5-9 and 13 of copending Application No. 18841460 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a method of treating or preventing a condition in a subject in need thereof, the method comprising administering benzaldehyde and a carrier, wherein the condition includes, but is not limited to, a bacterial infection, benzaldehyde is administered in a food at a concentration of 0.08wt % to about 50 wt%, as a liquid or vapor and by oral administration overlaps in scope with the method of treatment claimed in the instant Application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Therefore, No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
Prosecution Insights