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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 25 November 2025 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 7-9 and 20-25 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant states that support for the amendments can be found in the specification as originally filed and specifically in paragraphs 4, 7, 48, 50, 80 and 82
Paragraph 4 states “the device can cool the body surface or cavity to a temperature that inhibits growth of pathogens, changes in pathogen morphology, and/or disrupts biofilms.” However, this general statement about the device inhibiting/changing pathogens and/or disrupting biofilms makes no mention of pathogens that cause urinary tract infections contributing to preterm birth.
Paragraph 7 states “In some embodiments, the pathogen is a pathogen that causes a health condition selected from preterm labor, premature rupture of membranes, bacterial vaginosis, urinary tract infection, dermatophytosis, onychomycosis, tinea pedis, tinea cruris, rash associated with pendulous breasts, diaper rash, and/or the like.” This provides support for pathogens that cause urinary tract infections as alternatives to pathogens that cause preterm labor or premature rupture of membranes. This paragraph does not provide for the pathogen that causes urinary tract infections to be the same pathogen that causes preterm labor or premature rupture of membranes.
Paragraph 48 states “Embodiments of the invention also encompass a method of treating and inhibiting the abnormal growth of a pathogen, changing morphologies and disrupting biofilms on a body surface or cavity…” and goes on to discusses the method steps of freezing or cooling the device, placing the device and so on. This paragraph provides a general outline of a method of treating a pathogen on a body surface or cavity, but does not provide for the pathogen to be a pathogen that causes urinary tract infection or that such a pathogen contributes to preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes or such treatment free from use of a chemical.
Paragraph 50 states “The device acts via passive heat absorption….allowing the nail to grow normally and the tissue to heal….uses no systemic chemicals, is non-toxic, safe, and is faster-acting especially as it relates to tine cruris and pedis.” This paragraph does not provide for the pathogen to be a pathogen that causes urinary tract infection or that such a pathogen contributes to preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes.
Paragraph 80 specifically discloses that the frequency of urinary tract infections is increased in pregnancy and as a result antibiotics are administered during pregnancy to treat UTIs. These antibiotics shift the pH of the vagina which encourages the development of VVC which paragraph 78 associates with premature delivery and premature rupture of membranes. Paragraph 78 specifically states that “The purpose of this aspect of the invention is to introduce a non-chemical method to treat vaginal candidiasis and other microbial conditions of the vagina…” Here, Applicant has linked the administration of antibiotics to treat a urinary tract infection to a shift in vaginal pH which encourages the development of VVC that is then treatment by the method of the invention to prevent preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes. Therefore, it is the VVC which the method treats free from the use of chemicals to prevent preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes. Applicant has not linked pathogens that cause urinary tract infections to preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes or chemical free treatment of pathogens that cause urinary tract infections to prevention of preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes.
Paragraph 82 generally states that “Disclosed herein are method and deices for preventing or treating preterm birth, premature labor or contractions, premature cervical dilation or cervical incompetence, or premature rupture of membranes by the administration of a topical cooling device to a body cavity or surface for a sufficient frequency and duration of time to change microbial pathogen morphology, induce microbial dormancy, reduce biofilms, stop contractions, stop cervical dilation, or to prevent the occurrence of preterm birth or premature rupture of membranes before 37 weeks gestational age.” This paragraph provides a general outline of a method of treating a pathogen on a body surface or cavity, but does not provide for the pathogen to be a pathogen that causes urinary tract infection or that such a pathogen contributes to preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes or such treatment free from use of a chemical.
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 7-9 and 20-25 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 7 recites “applying the device to a body surface or cavity to inhibit growth of a pathogen on the body surface or cavity that can contribute to preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes free of use of a chemical to prevent preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes, wherein the pathogen causes urinary tract infection” and claims 20 and 25 recite “applying the device to a body surface or cavity to inhibit growth of a pathogen on the body surface or cavity free of use of a chemical to prevent preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes, wherein the pathogen causes urinary tract infection” and the specification does not provide for the connection between chemical free treatment of urinary tract infections and the prevention of preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes.”
The specification does not draw a connection between the treatment of pathogens that cause urinary tract infections free from use of a chemical and the prevention of preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes. In paragraphs 7 and 13 urinary tract infection is presented as an alternative health condition to preterm labor and premature rupture of membranes. Additionally, paragraph 80 specifically discloses that the frequency of urinary tract infections is increased in pregnancy and as a result antibiotics are administered during pregnancy to treat UTIs. These antibiotics shift the pH of the vagina which encourages the development of VVC which paragraph 78 associates with premature delivery and premature rupture of membranes. Paragraph 78 specifically states that “The purpose of this aspect of the invention is to introduce a non-chemical method to treat vaginal candidiasis and other microbial conditions of the vagina…” Here, Applicant has linked the administration of antibiotics to treat a urinary tract infection to a shift in vaginal pH which encourages the development of VVC that is then treatment by the method of the invention to prevent preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes. Therefore, it is the VVC which the method treats free from the use of chemicals to prevent preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes. Applicant has not linked pathogens that cause urinary tract infections to preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes or chemical free treatment of pathogens that cause urinary tract infections to prevention of preterm birth, premature labor or contractions, premature cervical dilation, premature cervical effacement or cervical incompetence or premature rupture of membranes.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN E SMITH whose telephone number is (571)270-5845. The examiner can normally be reached Monday-Friday 9am-5pm.
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/KAITLYN E SMITH/Primary Examiner, Art Unit 3794