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 .
Claim Status
Applicant's election with traverse of Group II (method claims) and the species of sodium dodecylbenzene sulfonate as the compound, penicillin as the antibiotic (antimicrobial), topical as the route of administration and Staphylococcus aureus as the microorganism in the reply filed on 08/04/2025 is acknowledged. The species of bacteria is extended to include methicillin resistant Staphylococcus aureus (MRSA).
The traversal is on the ground(s) that the Office has not shown that the prior art reference Burzell (cited WO2018/005659) teaches and suggests methods of treating or preventing a disease or condition in a subject. The Office has not shown that Burzelll teaches methods of preventing the growth of or removing or killing one or more microorganisms on a clinical surface using an effective amount of a composition comprising an organophosphorous or organosulfurous compound as claimed.
This is not found persuasive because the common technical feature of Groups I-II is treating microorganisms with a composition comprising one or more of organophosphorous or organosulfurous compounds, or salts, acids, or bases thereof having the structure of: formula I, II, III, IV or V. As set forth in Rule 13.1 of the Patent Cooperation Treaty (PCT), "the international application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept.” Moreover, as stated in PCT Rule 13.2, "where a group of inventions is claimed in one and the same international application, the requirement of unity of invention referred to in Rule 13.1 shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features." Furthermore, Rule 13.2 defines "special technical features" as "those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art." A lack of unity of invention determination begins with a consideration of the claims in light of the description and drawings. Lack of unity of invention may be directly evident “a priori,” or before considering any prior art when no special technical feature is common to each of the independent claims. Alternatively, lack of unity of invention may only become evident “a posteriori,” or after considering the claims in relation to the prior art
Burzell (WO2018/005659-See IDS filed on 04/05/2023) teaches treating conditions caused by one or more microorganisms in a subject such as biofilms by administering a composition comprising one or more organophosphorus compound of Formula I (paragraph 0043) or Formula IIA (paragraph 0057), see also paragraphs [00164], [0001], [0092], [0112]. Formula I is :
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140
183
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here A is C1-10 hydrocarbyl or optionally R1 substituted C1-10 hydrocarbyl; X is -NHR, -NHOR, -NHCOR, -NHOCOR, or -OR; and R is H or C1-10 hydrocarbyl;
R1 is selected from hydrogen, halogen, cyano, OH, C1-6 hydrocarbyl, C1-6 alkoxy, SOR2, SO2R2, SO2NR3R4 COR2, CO2R2, CONR3R4, NR3R4, NR3COR4, NR3SO2R4, NR3CO2R4, NR3CONR4, OCOR2, and phosphonic acid, wherein each of C1-6 hydrocarbyl, C1-6 alkoxy, SOR2, SO2R2, SO2NR3R4, COR2, CO2R2, CONR3R4, NR3R4, NR3COR4, NR3SO2R4, NR3CO2R4, NR3CONR4, OCOR2, can be optionally substituted with halo, amino, hydroxyl, C1-6 hydrocarbyl, C1-6 alkoxy, cyano, or phosphonic acid;
R2, R3 and R4 are independently selected from hydrogen, C1-6 hydrocarbyl, in which each of the C1-6 hydrocarbyl can be optionally substituted with halo, amino, hydroxyl, C1-6 alkoxy, cyano, or phosphonic acid. Burzell also expressly teaches the present of antibiotics.
Based on the prior art, the common technical feature of the instant claims lacks novelty over the prior art. Since the common technical feature is taught by the prior art, the common technical feature does not rise to the level of a special technical feature. Thus, the groups lack unity of invention a posteriori and restriction between them is proper. Accordingly, any subsequent patentably distinct invention lacks unity with the first group, see 37 CFR § 1.476 (d).
Applicants have argued the office has not shown that the combination of organosulfurous or organophosphorus compound with one or more antimicrobials or antimicrobial potentiators, probiotics, or prebiotics has a synergistic effect against various microorganisms and can reduce the MIC of the antimicrobials such as antibiotics by 64 fold or grater.
Examiner respectfully submits that this feature of a 64 or greater fold synergistic effect is not presently claimed. It is noted that the features upon which applicant relies (i.e., greater than 64 fold increase in MIC synergism) 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).
Claims 23-24, 26-34, and 42-43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/04/2025.
The requirement is still deemed proper and is therefore made FINAL.
Claims 44-50 are under current examination.
Information Disclosure Statements
Information Disclosure Statement (IDS) filed on 04/05/2023 has been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
Claim Rejections - 35 USC § 112(a)-Scope of enablement
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 44-50 are 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 treating a disease or condition including the elected Staphylococcus aureus, does not reasonably provide enablement for preventing a disease or condition caused by Staphylococcus aureus. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims without undue experimentation. MPEP 2164.01(a), citing In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), sets out the factors to consider whether experimentation is undue, which include:
(A) The nature of the invention. The claim is drawn to treating or preventing a disease caused by one or more microorganisms by administering one or more of organophosphorous or organosulfurous compounds, or salts, acids or bases thereof. The elected compound is sodium dodecylbenzene sulfonate. The elected microorganism is Staphylococcus aureus.
(B) The breadth of the claims. Prevention of a disease or condition including ones caused by Staphylococcus aureus is suggested to include a level of protection against, up to and including complete protection against the development of a disease or condition which is unsupported by the disclosure. Giving the claims their broadest reasonable interpretation in light of the specification, the term “preventing” includes any measure taken prior to the onset or occurrence of a disease or condition caused by Staphylococcus aureus microorganisms which precludes conditions or diseases caused by Staphylococcus aureus conditions coming into existence, absolutely and in all cases. Therefore, the term “preventing” renders the scope of the claims unreasonably broad.
(C) The level of predictability in the art. Preventing connotes an absolute absence of a condition or disease caused by Staphylococcus aureus which cannot reasonably be achieved with regard to the skin conditions or in medicine generally, with few exceptions (such as vaccines to prevent the development of pathogen-borne illnesses). In addition, there is no definitive method by which to determine whether a patient will develop a particular skin condition and, thus, be in need of preventive therapy. This is distinguished from preventing the relapse or recurrence of certain conditions, in which case an objective basis may exist to identify patients at risk of disease or infection, and could reasonably be construed as treatment. Prior to the initial onset or occurrence, however, even if a patient can be identified as having known risk factors for a condition, there is no certainty that the patient would in fact develop the condition. Further, the failure of a disease, or condition to develop cannot reliably be attributed to the claimed active agent(s). The non-development of a skin condition or infection may be due to other factors such as lifestyle, hygiene, or genetics. In this sense, in the context of preventing a condition or disease, the level of unpredictability is extremely high. According to NHS, it can be difficult to prevent infections caused by Staphylococcus because many people have the bacteria on their skin. There are steps to take to lower chances of getting an infection such as good hygiene, however it is difficult to completely prevent infection, see preventing staph infections. Sepsis Alliance teaches that two in 100 people carry MRSA and this bacteria is a risk for people who have compromised immune systems.. Close contact and shared living quarters increases the risk and that spread of MRSA can be minimized through proper hygiene. However, one in twenty patients contract an MRSA infection while receiving hospital care.
(D) The amount of direction provided by the inventor. While the specification provides examples of treating and killing bacteria administering organosulfurous compounds, no working examples in which infections are completely prevented are disclosed or tested for sodium dodecylbenzene sulfonate.
(E) The quantity of experimentation needed to make or use the invention. Because "preventing” a condition or disease by the administration of the claimed sodium dodecylbenzene sulfonate composition cannot be objectively measured or achieved with any certainty, coupled with a lack of guidance and direction provided by the instant disclosure, a skilled artisan could not practice the invention commensurate with the full scope of the claims without undue experimentation.
This rejection can be overcome by amending the claims to omit the term “preventing”.
Claim Rejections - 35 USC § 112
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 45 and 50 are 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.
Claim 45 recites the limitation "the structure shown in Tables 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear which structure of Tables 1-12 Applicants intend to refer to because Tables 1-12 each have multiple structures present. It is further noted that where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
Claim 50 recites one or more “microorganisms comprises” followed by a list of alternatives which is interpreted as an improper Markush grouping selected from the group comprising. A Markush grouping is a closed group of alternatives, i.e. selected from the group consisting of. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. Here, it is unclear what other alternatives are intended to be encompassed by the claim. See In re Kiely, 2022 USPQ2d 532 at 2* (Fed. Cir. 2022). It is suggested that Applicants can recite “wherein the one or more microorganism are selected from the group consisting of”.
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 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.
Claims 44-50 are rejected under 35 U.S.C. 103 as being unpatentable over Lockard et al. (United States Patent Publication 2015/0272925) in view of Aburawi et al. (The Possible Role of Vitamin C on the Effect of Penicillin G in Inactivating Bacterial Populations).
Applicants elected sodium dodecylbenzene sulfonate organosulfurous compound (structure V) together with the antibiotic (antimicrobial) comprising penicillin administered topically, with the microorganism causing disease or condition being Staphylococcus aureus. The election to Staphylococcus aureus is extended to methicillin resistant forms (MRSA).
Lockard et al. teach methods of cleaning skin by applying to skin (i.e. topically) sodium dodecylbenzene sulfonate together with an antibiotic, and vitamin C (ascorbic acid) see claims 22-23. The cleaning composition cleans skin that has been infected with bacteria and is effective to kill both gram negative and positive bacteria, see claims 30 and 33. The composition treats skin wounds infected with Staphylococcus aureus, see paragraph [0021], [0091]-[0093], [0171], [0235], Examples 6, 13-14 and entire document. The composition can treat MRSA infections, see paragraphs [0091]-[0103], Example 1 and entire document.
Lockard does not expressly teach that the antibiotic is penicillin (elected species).
However, Aburawi et al. teach that vitamin C (ascorbic acid) together with Penicillin G provided for a significant increase in the inhibitory effect on S. aureus, see discussion and conclusion.
It would have been prima facie obvious to substitute the antibiotic of Lockard for Penicillin G.
One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Lockard teaches that their antimicrobial composition contains vitamin C with antibiotic and per the teachings of Aburawi, Vitamin C potentiates the activity of the antibiotic Penicillin G. The simple substitution of Penicillin G for the antibiotics of Lockard would have yielded predictable results in killing S. aureus.
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 45-50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 49-52 and 56-61 of copending Application No. 18063911 (reference application) in view of Lockard et al. (United States Patent Publication 2015/0272925) in view of Aburawi et al. (The Possible Role of Vitamin C on the Effect of Penicillin G in Inactivating Bacterial Populations).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and that of Application ‘911 comprise the structure of sodium dodecylbenzene sulfonate (claim 50 of ‘911) wherein the composition kills bacteria on a surface.
The difference between the instant claims and that of Application ‘911 is that the claims of Application ‘911 do not recite killing of Staphylococcus aureus topically on a skin surface and a second antibiotic comprising penicillin present.
Lockard et al. teach methods of cleaning skin by applying to skin (i.e. topically) sodium dodecylbenzene sulfonate together with an antibiotic, and vitamin C (ascorbic acid) see claims 22-23. The cleaning composition cleans skin that has been infected with bacteria and is effective to kill both gram negative and positive bacteria, see claims 30 and 33. The composition treats skin wounds infected with Staphylococcus aureus, see paragraph [0021], [0091]-[0093], [0171], [0235], Examples 6, 13-14 and entire document. The composition can treat MRSA infections, see paragraphs [0091]-[0103], Example 1 and entire document.
Aburawi et al. teach that vitamin C (ascorbic acid) together with Penicillin G provided for a significant increase in the inhibitory effect on S. aureus, see discussion and conclusion.
It would have been obvious to treat and kill Staphylococcus aureus on skin surfaces including wounds with the sodium dodecylbenzene sulfonate of Application ‘911 because Lockard teaches that topically applying compounds such as dodecylbenzene sulfonate kill bacteria including Staphylococcus aureus on a skin wound surface. Furthermore, it would have been obvious to include penicillin G and ascorbic acid to help potentiate the antimicrobial activity.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 45-50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15,18,24, 32 of copending Application No 17597270 (reference application) in view of Lockard et al. (United States Patent Publication 2015/0272925) in view of Aburawi et al. (The Possible Role of Vitamin C on the Effect of Penicillin G in Inactivating Bacterial Populations).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and that of Application ‘270 comprise the structure of sodium dodecylbenzene sulfonate used in a method of preventing the growth of microorganisms on a surface. From claim 15 of Application ‘270, the compounds includes sodium dodecylbenzene sulfonate meeting the formula of the organosulfurous comounds of claim 1 in Application ‘270.
The difference between the instant claims and that of Application ‘270 is that the claims of Application ‘270 do not recite treating a disease caused by Staphylococcus aureus in a subject and a second antibiotic comprising penicillin present and administering the composition topically.
Lockard et al. teach methods of cleaning skin by applying to skin (i.e. topically) sodium dodecylbenzene sulfonate together with an antibiotic, and vitamin C (ascorbic acid) see claims 22-23. The cleaning composition cleans skin that has been infected with bacteria and is effective to kill both gram negative and positive bacteria, see claims 30 and 33. The composition treats skin wounds infected with Staphylococcus aureus, see paragraph [0021], [0091]-[0093], [0171], [0235], Examples 6, 13-14 and entire document. The composition can treat MRSA infections, see paragraphs [0091]-[0103], Example 1 and entire document.
Aburawi et al. teach that vitamin C (ascorbic acid) together with Penicillin G provided for a significant increase in the inhibitory effect on S. aureus, see discussion and conclusion.
It would have been obvious to treat and kill Staphylococcus aureus on skin surfaces with the sodium dodecylbenzene sulfonate of Application ‘270 because Lockard teaches that topically applying compounds such as dodecylbenzene sulfonate kill bacteria including Staphylococcus aureus on a skin wound surface. Furthermore, it would have been obvious to include penicillin G and ascorbic acid to help potentiate the antimicrobial activity.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Currently all claims are rejected and no claims are allowed.
Correspondence
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619