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 .
Claims 1-17 are presented for examination.
Applicant’s preliminary amendment filed September 1, 2023 has been received and entered.
Applicant’s information disclosure statements filed April 24, 2024 and July 15, 2024 have been received and entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
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 1-17 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.
This is a Written Description rejection.
A lack of adequate written description issue arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967).
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.
In particular, the specification as original filed fails to provide sufficient written bases of any of the agents demonstrating wherein possession of use of the broad terms: a related disease or condition thereof. The metes and bounds of the genus have not been appropriately defined. The mere fact that Applicant may have discovered one type of related disease or condition associated with cardiac arrest treated with a fluorocarbon emulsion is not sufficient to claim the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]."
Claims 1-17 are not allowed.
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 1-17 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 1 is rendered indefinite by the phrase “a related disease or condition thereof”. What is the disease or diseases related to a cardiac arrest? What are the conditions related to a cardiac arrest?
Claims 2-17 are rendered indefinite to the extent that they incorporate the above terminology.
Claims 1-17 are not allowed.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu et al., “Emulsified Isoflurane Combined With Therapeutic Hypothermia Improves Survival And Neurological Outcomes In A Rat Model Of Cardiac Arrest”, Experimental and Therapeutic Medicine, Vol. 13, No. 3, pages 891-898 (2017).
Wu et al. teach an emulsified isoflurane, a fluorocarbon having a boiling point of 48.5℃, in a composition being effective in a rat model of cardiac arrest (see the abstract). Clearly, the cited reference teaches the critical limitations of the instant invention for the treatment of cardiac arrest with a fluorocarbon having a boiling point between about -36℃ to about 105℃ in a composition that is an emulsion, therefore, the instant invention is unpatentable.
Claims 1 and 2 are not allowed.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al., “Emulsified Isoflurane Combined With Therapeutic Hypothermia Improves Survival And Neurological Outcomes In A Rat Model Of Cardiac Arrest”, Experimental and Therapeutic Medicine, Vol. 13, No. 3, pages 891-898 (2017) in view of Culp et al. (US 20014/0004099 A1) of PTO-1449.
Wu et al. were discussed above supra for a method of treating cardiac arrest with emulsified composition comprising isoflurane, a fluorocarbon with a boiling point of 48.5℃.
The instant invention differs from the cited reference in that cited reference does not teach other fluorocarbons such as perfluoropropane, perfluorobutane, perfluoropentane, perfluorohexane, perfluoroheptane, perfluorooctane, or a mixture of two or more in an emulsion that comprise nanodroplets or microbubbles. However, the secondary reference, Culp et al., teaches emulsions comprising dodecafluoropentane (DDFP) or perfluoropentane having five carbon atoms and PEG-Telomer B, a surfactant (title; abstract; paras. 0064, 0067-70, 0072, 0095- 0107). Culp teaches 2% w/v perfluorocarbon, specifically including dodecafluoropentane (DDFP), comprising 20g PFC and 3g PEG-Telomer B, per 1 liter batch in 33% sucrose solution (para.0095). The weight of the 33% sucrose solution is approximated at about 1.15 g/ml (Density of aqueous solutions of organic substances as sugars and alcohols. Note the nanoemulsions comprise a droplet “whose diameter, in general, exceeds approximately 100 nm” (para.0067), is about 250 nanometers (para.0074), or under 400 nm (paras.0106-07). Culp does not expressly state that 99% of the particles have a diameter under 400 nm. However, the “initial average particle diameters” were under 400 nm and the “particle size remains stable at a diameter below 400 nm” (para. 0107) and therefore the particles would meet the recited limitation. At the least such nanoemulsion compositions would have been prima facie obvious to one of ordinary skill in the art due to Culp’s express teachings. Note para. (0070) teaches phospholipids from about 12 to about 20 carbons are useful in the emulsion. Note para. (0075) teaches the emulsion can be administered by injection, namely intravenously. Also note para. (0076) teaches emulsion can be administered in a bolus and continuously administered in an infusion. Note para. (0078) teaches the infusion is IV infusion preferably from about 0.05 to about 0.3 cc per kg (convert to 50 mg/kg to 300 mg/kg).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute perfluoropentane (also known as dodecafluoropentane) for isoflurane in the treating of cardiac arrest with a predictable expectation of successful treatment due to the compounds’ structural and functional similarities.
Claims 1-17 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN E WEDDINGTON whose telephone number is (571)272-0587. The examiner can normally be reached M-F 1:30-10:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeff 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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KEVIN E. WEDDINGTON
Primary Examiner
Art Unit 1629
/KEVIN E WEDDINGTON/Primary Examiner, Art Unit 1629