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.
Election/Restrictions
The requirement for restriction/election dated 02/18/2025 is upon reconsideration withdrawn. Claims 1-18 are pending in the application and are currently under examination.
Claim Rejections - 35 USC § 112, Second Paragraph
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 1-18 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.
Regarding broad to narrow limitation, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 1 recites the broad recitation “the subject has low blood pressure during the surgery” and the claim also recites “preferably wherein the blood pressure is less than 90 mmHg systolic” in line 7, which is the narrower statement of the range/limitation.
Claim 1 recites the broad recitation “O2 is present in an amount of from about 91% to about 99% by volume” and the claim also recites “preferably from about 93% to about 97% by volume” in line 10, which is the narrower statement of the range/limitation.
Claim 1 recites the broad recitation “CO2 is present in an amount of from about 1% to about 9% by volume” and the claim also recites “preferably from about 3% to about 7% by volume” in line 12, which is the narrower statement of the range/limitation.
Claim 2 recites the broad recitation “O2 is present in an amount of from about 91% to about 99% by volume” and the claim also recites “preferably from about 93% to about 97% by volume” in line 8, which is the narrower statement of the range/limitation.
Claim 2 recites the broad recitation “CO2 is present in an amount of from about 1% to about 9% by volume” and the claim also recites “preferably from about 3% to about 7% by volume” in line 10, which is the narrower statement of the range/limitation.
Claim 4 recites the broad recitation “wherein the surgery is vascular surgery, the surgery requires relaxed blood vessels, and the surgery involves arterial catheterisation” and the claim also recites “preferably wherein the surgery involves cardiac angiogram, cardiac stent placement, rotablation, and/or intra-arterial balloon tamponading” in lines 3-4, which is the narrower statement of the range/limitation.
Claim 7 recites the broad recitation “before and/or during surgery” and the claim also recites “preferably before surgery, more preferably before both surgery and anaesthesia” in line 3, which is the narrower statement of the range/limitation.
Claim 8 recites the broad recitation “obese” and the claim also recites “preferably having a Body Mass Index (BMI) of greater than 35 kg/m3” in line 3, which is the narrower statement of the range/limitation.
Claim 8 recites the broad recitation “low functional residual lung capacity” and the claim also recites “preferably an FRC of less than 30 mL/kg when measured in the supine position” in lines 5-6, which is the narrower statement of the range/limitation.
Claim 10 recites the broad recitation “wherein the use is when the subject is under general anesthesia, or before general anesthesia is administered” and the claim also recites “preferably before general anesthesia is administered” in line 3, which is the narrower statement of the range/limitation.
Claim 13 recites the broad recitation “carrier gas” and the claim also recites “preferably wherein the carrier gas comprises nitrogen (N2), helium (He), xenon (Xe), argon (Ar), krypton (Kr) or a mixture thereof” in lines 3-5, which is the narrower statement of the range/limitation.
Claim 15 recites the broad recitation “O2 is present in an amount of from about 91% to about 99% by volume” and the claim also recites “preferably from about 93% to about 97% by volume” in line 3, which is the narrower statement of the range/limitation.
Claim 15 recites the broad recitation “CO2 is present in an amount of from about 1% to about 9% by volume” and the claim also recites “preferably from about 3% to about 7% by volume” in line 5, which is the narrower statement of the range/limitation.
Claim 16 recites the broad recitation “carrier gas” and the claim also recites “preferably wherein the carrier gas comprises N2, He, Xe, Ar, Kr or a mixture thereof” in lines 3-5, which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the features introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. To overcome these rejections, “preferably” language can be removed from the claims.
Claim 1 recites, “wherein it is desirable…” in line 5. This language is indefinite because it is not clear whether the limitations that follow are required features of the claim.
Claim 1 recites “low blood pressure” (line 5), “high blood loss” (line 6) and “relaxed blood vessels” (line 6). This language is indefinite because “low”, “high”, and “relaxed” are relative terms which are not defined in the specification.
Regarding claim 3, the phrase "amongst other" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "amongst others"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claim 4 recites “relaxed blood vessels” (line 2). This language is indefinite because “relaxed” is a relative term which is not defined in the specification.
Regarding claim 6, the phrase "such as" in line 3 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 6 recites “limited blood flow or oxygen” (line 3) and “high blood pressure” (lines 3-4). This language is indefinite because “limited” and “high” are relative terms which are not defined in the specification.
Claim 8 recites “obese” (line 3) and “low functional residual lung capacity” (line 5). This language is indefinite because “obese” and “low” are relative terms which are not defined in the specification.
Claim Rejections - 35 USC § 102
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.
Claims 1-12, 14-15, and 17-18 are rejected under 35 U.S.C. 102 as being as being anticipated by Dharmakumar et al. (US 2014/0170069 A1).
Claims 1-11, 15, and 18 are anticipated because Dharmakumar discloses mixtures of carbon dioxide and oxygen, such as “medical grade carbogen” which is 5 vol.% CO2 and 95 vol.% O2 and additional mixtures such as 94 vol.% O2, and 6 vol.% CO2 [0098].
If the prior art discloses a point within the claimed range, the prior art anticipates the claim. See MPEP 2131.03.
The instant claims are directed to a product (composition). The limitations of the use of the composition in the treatment or prevention of at least one complication associated with surgery on a subject (claim 1), the use in the treatment or prevention of at least one complication associated with apnea in a subject during anesthesia (claim 2), a specific surgery type (claims 3-5), the use for a specific complication (claim 6), the use before and/or during surgery (claim 7), the use with an obese subject or one with low functional residual lung capacity (claim 8), the composition being administered under normobaric conditions (claim 9), use when the subject is under general anesthesia (claim 10), administration by inhalation (claim 11), and for use as a medicament (claim 18) are all intended uses of the composition.
The composition as claimed is anticipated by Dharmakumar and the composition of Dharmakumar appears to be capable of meeting the intended use of the instant claims as it is administered to patients by inhalation to alleviate the severity of a disease condition, prevent a disease condition from worsening, or lower the chances of a patient developing a disease (abstract) [0021] [0060] [0062] [0097]. As the composition of Dharmakumar is an inhalable gas for medical use it would be reasonably expected to be able to be used before and/or during surgery or anesthesia for any of the claimed surgeries or patient types under the claimed conditions.
Claim 12 is anticipated because Dharmakumar discloses 5 vol.% CO2 and 95 vol.% O2 [0098].
Claims 14 and 17 are anticipated because Dharmakumar discloses 94 vol.% O2, and 6 vol.% CO2 [0098].
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 13 and 16 are rejected under 35 U.S.C. 103 as being as being obvious over Dharmakumar et al. (US 2014/0170069 A1) in view of Abraini (US 2010/0278942 A1).
Claims 1-12, 14-15, and 17-18 are anticipated by Dharmakumar as discussed above.
Dharmakumar does not disclose a carrier gas in an amount of greater than 0 to about 8% by volume, as recited in claims 13 and 16.
Abraini teaches an inhalable gas mixture [0016] [0057] (claim 14) (abstract) with helium in an amount between 1 and 40 vol.% [0021]. Abraini teaches that helium is cardioprotective and/or neuroprotective [0009] [0012].
Since Dharmakumar generally teaches an inhalable gas mixture, it would have been prima facie obvious to one of ordinary skill in the art to include helium in an amount of 1-40 vol.%, within the teachings of Dharmakumar, because Abraini teaches this amount of helium in an inhalable gas. An ordinarily skilled artisan would be motivated to use helium, in the amount taught by Abraini, for its cardioprotective and/or neuroprotective properties [0009] [0012].
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05 A.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashlee E Wertz whose telephone number is (571)270-7663. The examiner can normally be reached Monday - Friday, 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Frederick Krass can be reached on 571-272-0580. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHLEE E WERTZ/ Examiner , Art Unit 1612
/FREDERICK F KRASS/Supervisory Patent Examiner, Art Unit 1612