DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Notice of Pre-AIA or AIA Status
Claims 1-20 are pending.
Priority
This application, filed 10/11/2024 is a CON of application U.S. 14/618,820 filed 02/10/20215 which is a CIP of application U.S. 13/770,738 (“the ‘738 application) filed 02/19/2013 that claims priority from a provisional US patent application 61/600,344 (“the ‘344 application”) filed on 02/17/2012. Priority for the current claims is not found in either the ‘738 application nor the ‘344 application, specifically methods of treating udders or mastitis.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-4, 11-13, and 15 are rejected under pre-AIA 35 U.S.C. 102(b) as
being anticipated by Stevenson, D.V., et al., U.S. Patent 5,456,211.
Stevenson teaches methods of methods of disinfecting to treat or prevent
infection (i.e. mastitis) of COW udders by bathing/dipping the udders in a disinfectant and
coloring solution comprising hypochlorite and acetic acid promptly after milking,
compare instant claims 1-4, 11-13, and 15. (See column 3 lines 10-50.)
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-5 and 11-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being
unpatentable over Stevenson, D.V., et al., U.S. Patent 5,456,211 in view of Corby,
M.P., U.S. Patent 4,983,634.
Stevenson teaches methods of methods of disinfecting to treat or prevent
infection (i.e. mastitis) of COW udders by bathing/dipping the udders in a disinfectant and
coloring solution comprising hypochlorite and acetic acid promptly after milking. (See
column 3 lines 10-50.)
Stevenson does not teach applying the disinfecting hypochlorite/hypochlorous
acid comprising compositions through the teat canal to treat the mastitis infections.
Corby teaches applying disinfecting hypochlorite/hypochlorous acid comprising
compositions through the teat canal to treat the mastitis infections using an applicator to
infuse the solution into the infected udder. (See claims 1-8.)
It would have been prima facie obvious to one of ordinary skill in the art at the
time of the invention to further prevent and/or treat mastitis and infections of COW udders
by applying hypochlorous acid disinfecting solutions to the infected portions of the udder
by infusing them into the teat of the COWS as taught by Corby in the methods of
Stevenson. This is merely the use of a common method of providing hypochlorous
antimicrobial compositions to COW udders in methods requiring the treatment of cow
udders with acetic acid hypochlorous antimicrobial compositions.
Claims 6-10 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stevenson, D.V., et al., U.S. Patent 5,456,211 and Corby, M.P., U.S. Patent 4,983,634 as applied to claims 1-5 and 11-15 above, and further in view of Kuroiwa, K., et al., (Lett. Appl. Microbio., 2003) and Wang, L., et al., (J. Burns Wounds, 2007).
Stevenson and Corby teach methods of treating or preventing mastitis or udder
infections by applying hypochorous acid to and into the teats of the animals as
discussed above.
Stevenson and Corby do not teach the specific pH of the materials, buffering the
materials, or restricting the air/headspace of the solutions.
Kuroiwa teaches combining hypochlorite with acetic acid and adjusting the pH to
5.0 in order to increase the antibacterial activity of the hypochlorous solutions and
reduce the amount of chlorine gas present. (See abstract.)
Wang teaches using hypochlorous acid as a wound care agents, maintaining the
pH of the acid at pH 3.5-5 in order to minimize undesirable side products like chlorine
gas and maximize the HOCI. (See abstract and figure 2.) Wang teaches that Cl₂ gas is
formed in the headspace of HOCI solutions due to the equilibrium between Cl₂ and
HOCI and an open headspace (non-sealed) results in a decrease in active chlorine
concentrations and control over time. Wang teaches that control over this reaction is
utilized in industrial practice to optimize the availability of HOCI. (See page 70
paragraph 1 and page 75, paragraph 2.)
It would have been prima facie obvious to one of ordinary skill in the art at the
time of the invention to control the pH of the hypochlorous acetic acid solutions of
Stevenson and Corby given the teachings of Kuroiwa and Wang to buffer and control
the pH at around pH 3.5-5 in order to decrease the chlorine gas in the solutions and
increase the active disinfectant HOCI in the solutions. The skilled artisan would have
been motivated to make this combination in order to stabilize the HOCI as well as
provide higher antimicrobial abilities for the solutions. The skilled artisan would have
also have been motivated to remove the headspace and air from such solutions in order
to prevent the equilibrium between HOCI and Cl₂ gas moving towards the formation of
Cl₂ gas in order to control and maintain high amounts of HOCI in the solutions as taught
by Wang. This is merely the use of commonly accepted industrial techniques used to
control HOCI concentrations by pushing the equilibrium away from the formation of Cl₂
gas and towards the solution phase HOCI.
Claims 1-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stevenson, D.V., et al., U.S. Patent 5,456,211; Corby, M.P., U.S. Patent 4,983,634; Kuroiwa, K., et al., (Lett. Appl. Microbio., 2003); and Wang, L., et al., (J. Burns Wounds, 2007) as applied to claims 1-20 above, and further in view of Abel, D., et al., U.S. Patent Application Publication 2012/0148516.
Stevenson, Corby, Kuroiwa, and Wang teach methods of treating or preventing mastitis or udder infections by applying hypochlorous acid to and into the teats of the animals where the acid is at pH 3.5-5 and has no air or headspace to allow formation of Cl₂ gas as discussed above.
Stevenson, Corby, Kuroiwa, and Wang do not teach providing argon instead of
air in such compositions.
Abel teaches topical compositions for treating dermatological compositions. (See
abstract.) Abel teaches including bleach compositions such as Microcyn (a stabilized pH
balanced hypochlorous acid solution) in the formulations. (See paragraph 0105.) Abel
teaches providing such compositions without air by purging them with argon or nitrogen.
(See paragraphs 0725-0726.)
It would have been prima facie obvious to one of ordinary skill in the art at the
time of the invention to purge hypochlorous acid bleach compositions with argon as
taught by Abel in the methods of Stevenson, Corby, Kuroiwa, and Wang requiring hypochlorous acid compositions in order to prevent reaction of the formulations with the constituents of air. The skilled artisan would have been motivated to make this combination in order to prevent any unwanted reactions in the disinfecting materials during storage.
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 claims at issue 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); and 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 a nonstatutory
double patenting ground provided the reference application or patent either is shown to
be commonly owned with this 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 §§ 706.02(I)(1) - 706.02(I)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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
http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-Il.jsp.
Claims 1-20 are provisionally rejected on the ground of nonstatutory
double patenting as being unpatentable over claims 1-24 of copending Application No. 15/167,076 in view of Stevenson, D.V., et al., U.S. Patent 5,456,211
and Corby, M.P., U.S. Patent 4,983,634.
Although the claims at issue are not identical, they are not patentably distinct
from each other because: The co-pending application teaches compositions comprising hypochlorous acid, acetic acid at a pH of 3.7-5.8 and 4.76 in an air-free environment and methods of using these compositions to treat wounds and skin infections. The co-pending application does not teach using such compositions for the specific infections such as mastitis in cattle.
Stevenson teaches methods of methods of disinfecting to treat or prevent infection (i.e. mastitis) of COW udders by bathing/dipping the udders in a disinfectant and coloring solution comprising hypochlorite and acetic acid promptly after milking. (See column 3 lines 10-50.)
Corby teaches applying disinfecting hypochlorite/hypochlorous acid comprising compositions through the teat canal to treat the mastitis infections using an applicator to infuse the solution into the infected udder. (See claims 1-8.)
It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to further prevent and/or treat mastitis and infections of COW udders by applying hypochlorous acid disinfecting solutions of the co-pending application to the infected portions of the udder by infusing them into the teat of the COWS as taught by Corby and Stevenson. This is merely the use of a common method of providing hypochlorous antimicrobial compositions to COW udders in methods requiring the treatment of COW udders with acetic acid hypochlorous antimicrobial compositions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT S CABRAL/Primary Examiner, Art Unit 1614
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