DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Amendments and Remarks, filed 2 September 2025, in the matter of Application N° 18/017,133. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 4, 5, 13, 19, and 20 have been canceled. Claims 21-24 are newly added. Claims 23 and 24 are supported be the previously presented claims. Claims 21 and 22 are supported by the originally-filed disclosure (see pg. 27, lines 1-2).
Claims 1, 6, 8, 9, 12, 14, 15, and 17 have been amended. The limitations of canceled claims 4, 5, and 13 have been added to claim 1. Claim 6 is amended to depend from claim 1 and is now punctuated. Claim 8 is amended to remove the word ‘substantially’ and to correct the spelling of ‘allicin’. Claim 12 also corrects the spelling of ‘allicin’. Claims 9, 14, and 15 are amended to harmonize the preamble to claim 1. Claims 14 and 15 are amended to depend from claim 1. Claim 17 is amended to correct the term ‘feed’.
No new matter has been added.
Thus, claims 1-3, 6-12, 14-18, and 21-24 now represent all claims currently under consideration.
Information Disclosure Statement
One new Information Disclosure Statements (IDS) filed 2 September 2025 is acknowledged and has been considered.
Withdrawn Rejections
Rejection under 35 USC 112
Applicants’ amendment removing the term ‘substantially’ from claim 8 persuasively overcomes the previously raised indefiniteness rejection. Said rejection is withdrawn.
Rejection under 35 USC 101
Applicants’ amendments of the canceled limitations of claims 4, 5, and 13 into claim 1 are persuasive in making the previously rejected composition patent-eligible. Said rejection is withdrawn.
Rejections under 35 USC 102
Applicants’ amendments to claim 1 add subject matter that was not rejected in either of the previously raised anticipation rejections. Said rejections are withdrawn.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 10 June 2025 since the art that was previously cited continues to read on the recited limitations.
Claim Rejections - 35 USC §103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. Applicants are 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.
Claims 1-3, 6-12, 14-18, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Hile et al. (J. Agric. Food Chem.; 2004) with evidence provided by Wang et al. (J. Sulfur Chemistry; 2013) and further in view of Groom et al. (US Pre-Grant Publication Nº 2010/0069674 A1). [emphasis added to reflect added/canceled claims]
The limitations of claims 1-3 and 8-12, and 14-18 are discussed above. As discussed above, the limitations of claim 1 now include comprising acetic acid and a pH of 4-6. Claims 6 and 7 narrow the pH range (e.g., 4.2-4.9).
The teachings of Hile are discussed above, as are the supporting, art-defining disclosures of both Wang and Groom (included herein below for Applicants’ convenience):
Hile discloses granules impregnated with 50% food-grade garlic oil (GO) (see e.g., Abstract), which as defined and disclosed by Wang, is shown to “give families of polysulfanes with up to 22 sequential sulfur atoms,” further defining such compounds as possessing the following structure and variable definitions:
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Thus, the disclosure of garlic oil is considered to inherently contain the foregoing compound.
The limitations of claims 8 and 11 are considered to be met in view of defining evidence provided by Groom. Therein, the plant from which garlic oil is extracted, Allium sativum, is also recognized by the state-of-the-art as containing allicin (see Groom; Abstract; ¶[0011]).
The limitations of claim 9 are considered to be met by the disclosure of that garlic oil contains additional sulfide compounds such as allyl methyl disulphide (see e.g., pg. 2195; right col., lines 1-8 of the third full paragraph).
The foregoing is additionally considered to disclose the limitations of claims 13-15. Claim 15 recites that the animal feed composition is administered in animal drinking water. The claim is considered to read on the claimed feed as disclosed by Hile since the water element of the claim is not considered to further limit the claim. Stated another way, the Examiner broadly and reasonably considers the recited composition as being directed to the feed composition of claim 13 and not the water to which in which it is administered (e.g., a intended use of the claim).
The limitations of claims 10-12 are considered to be met by the disclosure of Hile, as further defined by Groom. Therein, Groom defines the garlic plant as containing both alliin and alliinase, the latter of which is disclosed as being the enzyme responsible for producing (i.e., a precursor) allicin.
Lastly, the limitations of claims 16 and 17 recite a method comprising administering to an animal, the composition of claim 1, in a treating, in a controlling, or in a reducing a likelihood of ectoparasitic infestation amount. The form of animal administration is as an animal feed.
The foregoing teachings are, again, considered to meet the recited limitations as Hile discloses administering a 50% garlic oil infused granular feed to starlings. As defined by Wang, garlic oil is defined as inherently containing polysulfanes with up to 22 carbon atoms and that research of interest is directed to demonstrating the compounds as being benign nematicides (see Introduction; pp. 55-56). Groom additionally defines polysulfide molecules with higher sulphur chain lengths (i.e., containing more than three sulphur atoms) as being very active with increasing evidence of a very wide range of biological activity (i.e., insecticidal, nematicidal, mollusicidal, repellent, anti-cancer, antibiotic and fungicidal). See Groom ¶[0005]. As such, Hile’s disclosure of garlic oil-infused bird feed is considered to meet the method limitations of claims 16 and 17. On its face, the positively recited limitations of the method require administering the composition to an animal and in the form of feed. The limitations directed to treating, controlling, or reducing the likelihood of an ectoparasitic infestation are considered to be met as the state of the art recognizes the family of polysulfide molecules as having such biological activity.
Where Hile is deficient, however, is with respect to the inclusion of acetic acid in its practiced composition. Groom is considered to remedy this deficiency.
Groom, as discussed briefly above, is directed to processing of garlic or Allium sativum to produce polysulfides (see Abstract; ¶[0011]). In this particular procedure, allicin-containing plant extract is combined with elemental sulfur, the mixture heated, and the pH controlled in order to manipulate the length of the polysulfide chain (see Abstract; ¶[0015]). Paragraph [0015] teaches that the pH adjusting step is carried out using such acids as acetic acid and that the pH is adjusted between a pH of below 4 to a pH of 8 (see e.g., claims 8 and 12; ¶[0014]).
Regarding the length of the polysulfide chains produced, ¶[0005] discloses that “[p]olysulfide molecules with higher sulphur chain lengths (S=>3, i.e. containing three or more sulphur atoms) are also very active with increasing evidence of a very wide range of biological activity (insecticidal, nematicidal, mollusicidal, repellent, anticancer, antibiotic and fungicidal).” The passage further exemplifies diallyl trisulfide and diallyl tetrasulfide, while the reference provides added disclosure of polysulfides up to six sulfur atoms in length (i.e., DAS6).
The reference does not expressly disclose polysulfides having a chain length of eight sulfur atoms or longer, despite teaching and suggesting an open-ended range of sulfur atoms.
Based on the combined teachings of the references, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition and arriving at the recited method of administering said compositions.
The teachings of Wang are considered to provide added motivation as it is pointed out that the reference discloses that garlic oil is understood as containing polysulfanes (aka polysulfides) within it and in lengths of up to 22 sulfur atoms in length. When paired with the teachings of Groom, the ordinarily skilled artisan would understand that Groom’s open-ended sulfur chain disclosure would be inclusive of longer chains and there would be an expectation that such polysulfide compounds would possess biological activity (e.g., nematicide) as is discussed by both references.
Thus, with regard to the acetic acid and pH limitations of the claimed invention, a person of ordinary skill in the art would have found it obvious to include an acid such as acetic acid in the claimed composition, particularly as the art recognizes it as being part of the process for producing polysulfide compounds of increased length.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 1-3, 6-12, 14-18, and 21-24 under 35 USC 103(a) as being unpatentable over the combined teachings of Hile et al., Wang et al., and Groom et al. have been fully considered, but they are not persuasive.
Applicants initial traversal of the rejection is on the grounds that “Wang teaches that higher DASn [diallyl polysulfone] compounds are formed when GO [garlic oil] is treated with elemental sulfur S8 (see Wang’s Fig. 4, where compounds where n = 4-17 are formed after liquid S8 treatment), i.e., GO itself does not contain the higher DASn compounds.”
The Examiner, in response, disagrees.
Turning to Figure 4 of Wang, the Examiner notes that the profiles depicted therein show that S8 and S9 is present in both the before and after profiles. Regardless, of this disclosure, the Examiner submits that the method of arriving at the claimed DASn is not at issue; instead, the compound itself. The Examiner thus respectfully maintains that Wang discloses said compound(s).
Applicants next delve into the process by which garlic oil understood to be formed, presenting the teachings of O’Gara et al. discussing its preparation using steam distillation, for instance.
Here, the Examiner finds this discussion unpersuasive because, as mentioned above, the process by which garlic oil or the DASn compound at issue, is in fact, not at issue. Applicants’ submission of the Dewi reference is similarly considered unpersuasive, particularly as Wang demonstrates that the recited compound is derived from garlic oil.
Applicants’ remarks directed to instant Example 11 pertaining to the extraction method used to produce compounds of formula (I) are not persuasive since the instant invention is directed to a composition and a method of treating, rather than methods for manufacturing anything.
Applicants’ summation of the remaining Examples set forth in the disclosure is unpersuasive for the same reason.
Applicants’ next re-assert that Wang does not teach GO as possessing DASn compounds as recited, and further argue that Hile teaches away from the use of DASn compounds in animal feed, as the GO-impregnated granules were found to be unpalatable.
The Examiner respectfully acknowledges that while the practiced composition is disclosed as being repellent to certain avian species, that the reference still discloses it as being a feed or food mixture.
Applicants’ remark that Wang teaches the DASn compounds with higher n values can be formed is acknowledged. However, the Examiner again reiterates that Wang also discloses DASn compounds that meet the claimed formula (I) compound both before and after treatment. Regardless, the Examiner again maintains that the methods of preparing formula (I) are not at issue.
Applicants further add that the thesis published by Arbach speaks to the alleged instability of the DASn compounds in general.
The Examiner notes that while the methods by which the recited compound are not at issue, the Arbach reference appears to report that the most common manner by which DAS compounds are extracted from garlic is through steam distillation. The Examiner submits that the combined teachings of record disclose the use of acetic acid, specifically Groom (see ¶[0014]) which discloses producing polysulfides of increased chain length through the use of pH adjusting agents such as acetic acid.
Thus, in view of the art recognized instability of higher-length chain species of DASn compounds, the Examiner respectfully maintains that a person of skill in the art would turn to such teachings as Groom in order to improve the stability of such a compound.
Applicants’ remark that Groom fails to expressly teach or suggest the use of longer polysufide compounds in a feed composition are unpersuasive, notably as this is already established by Hile and Wang.
Applicants’ arguments, for the above reasons, are found unpersuasive. Said rejection is therefore maintained, and extended to include newly presented claim 21-24. Therein, the limitations of claims 23 and 24 are considered to be met by the teachings already of record. The limitations of claims 21 and 22 are broadly and reasonably considered to be met by the cited combined teachings as further considered in view of the MPEP §2112.01(I).
All claims under consideration remain rejected; no claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicants are 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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615