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 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 1-19 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 (the rest by dependency) recite “the breath”. There is insufficient antecedent basis for this limitation. Examiner assumes the limitation to read “the exhaled breath”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites limitations directed to the use of the claimed apparatus. Thus, claim 2 fails to structurally limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1-4, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orlandi et al. (WO 2020/021407 A1 – cited by Applicant), hereinafter Orlandi in view of Olsson et al. (WO 2012/033455 A1 – cited by Applicant), hereinafter Olsson.
Regarding Claim 1, Orlandi teaches: An apparatus for collecting part of an exhaled breath, comprising:
a chamber (container SA including bag BG; figure 2)comprising:
an inlet end through which the breath enters the sample collection volume (figure 2; C1); and
an outlet end through which the breath exits the sample collection volume (figure 2; C2);
two closures, one at each of the inlet end and the outlet end to control passage of the breath through the respective inlet end or outlet end (figure 2; T1 and T2), the closures being actuated to capture the part of the exhaled breath (page 12 lines 20-25; taps are actuated); and
a sampling port accessible from outside the chamber and in communication with the sample collection volume (acquisition port 8),
wherein the chamber has a longitudinal extent, and has a taper in its diameter toward each of the inlet end and outlet end (figure 2).
Orlandi does not mention an internal surface defining a sample collection volume, that has been functionalised so that it does not interact chemically or physically with volatile components in the breath.
Olsson teaches an internal surface defining a sample collection volume, that has been functionalised so that it does not interact chemically or physically with volatile components in the breath (page 3 lines 15-20). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the apparatus to include an internal surface defining a sample collection volume, that has been functionalised so that it does not interact chemically or physically with volatile components in the breath.
Regarding Claim 2, Orlandi in view of Olsson teach: An apparatus according to claim 1, being used for the collection of end tidal breath (Examiner notes that this limitation represents intended use, and thus lacks patentable weight).
Regarding Claim 3, Orlandi in view of Olsson teach: An apparatus according to claim 1, wherein the internal surface has been functionalised by being silanized (Olsson - page 3 lines 15-20).
Regarding Claim 4, Orlandi in view of Olsson teach: An apparatus according to claim 3. While Orlandi mentions the use of a polymeric material, Orlandi does not explicitly mention wherein the chamber is formed from glass or any chemically inert materials.
Olsson teaches the use of glass/plastic (Olsson - page 3 lines 15-20). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the apparatus to include wherein the chamber is formed from glass or any chemically inert materials so that it does not interact chemically or physically with volatile components in the breath.
Regarding Claim 18, , Orlandi in view of Olsson teach: An apparatus according to claim 1, wherein the taper is selected to maintain laminar flow of breath through the chamber (Examiner notes that this limitation represents intended use, and lacks patentable weight; Orlandi - figure 2 shows a taper that is capable of maintaining laminar flow).
Regarding Claim 19, Orlandi in view of Olsson teach: An apparatus according to claim 1, wherein the chamber is substantially cylindrical, having a longitudinal axis extending through both the inlet end and outlet end (figure 2).
Claim(s) 5-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orlandi in view of Olsson in view of Cai et al. (US 2017/0227508 A1), hereinafter Cai.
Regarding Claim 5, Orlandi in view of Olsson teach: An apparatus according to claim 1, but do not mention wherein the sample collection volume is a predetermined internal volume that is less than a full exhalation volume.
Cai mentions a typical volume for breath sampling to be around 70ml (paragraph 0026). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the apparatus wherein the sample collection volume is a predetermined internal volume that is less than a full exhalation volume in order to sufficiently capture exhaled breath while avoiding dead space.
Regarding Claim 6, Orlandi in view of Olsson in view of Cai teach: An apparatus according to claim 5, wherein the predetermined volume is between about 30 mL and about 400 mL (Cai - paragraph 0026).
Regarding Claim 7, Orlandi in view of Olsson in view of Cai teach: An apparatus according to claim 6, wherein the predetermined volume is between about 70 mL and about 350 mL (Cai - paragraph 0026).
Regarding Claim 8, Orlandi in view of Olsson in view of Cai teach: An apparatus according to claim 7, wherein the predetermined volume is about 70 mL (Cai - paragraph 0026).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orlandi in view of Olsson in view of Atsalakis (US 2019/0120821 A1).
Regarding Claim 9, Orlandi in view of Olsson teach: An apparatus according to claim 1, but do not explicitly mention wherein the closure at the inlet end comprises a valve.
Atsalakis teaches the use of a one way valve at the inlet (paragraph 0023). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the apparatus to include wherein the closure at the inlet end comprises a valve to avoid a user rebreathing exhaled air.
Regarding Claim 10, Orlandi in view of Olsson further in view of Atsalakis teach: An apparatus according to claim 9, wherein the valve is a one-way valve to permit passage of breath into the chamber and to prevent passage of breath out of the chamber through the inlet end (Atsalakis – paragraph 0023).
Claim(s) 11, 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orlandi in view of Olsson in view of Bhatnagar et al. (US 2015/0065901 A1), hereinafter Bhatnagar.
Regarding Claim 11, Orlandi in view of Olsson teach: An apparatus according to claim 1 but do not explicitly mention wherein the closure at the outlet end comprises a valve.
Bhatnagar teaches the use of a one way valve at the outlet (paragraph 0055; figure 19). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the apparatus wherein the closure at the outlet end comprises a valve to control what part of the exhaled breath is captured.
Regarding Claim 14, Orlandi in view of Olsson teach: An apparatus according to claim 1, but do not explicitly mention wherein the closure at the outlet end operates independently of the closure at the inlet end.
Bhatnagar teaches wherein the closure at the outlet end operates independently of the closure at the inlet end (paragraph 0055; figure 1-5). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the apparatus wherein the closure at the outlet end operates independently of the closure at the inlet end in order to have more control of the breath sample being captured/stored.
Regarding Claim 15, Orlandi in view of Olsson further in view of Bhatnagar teach: An apparatus according to claim 14, wherein the sampling port is formed in one of the two closures (Orlandi acquisition port 8; page 11-page 13).
Regarding Claim 16, Orlandi in view of Olsson further in view of Bhatnagar teach: An apparatus according to claim 14. Orlandi in view of Olsson do not mention wherein the sampling port is disposed between the inlet end and the outlet end.
Bhatnagar teaches wherein the sampling port is disposed between the inlet end and the outlet end (figure 19). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the apparatus to include wherein the sampling port is disposed between the inlet end and the outlet end as the substitution of one sampling location for another would have yielded predictable results to one of ordinary skill.
Regarding Claim 17, Orlandi in view of Olsson further in view of Bhatnagar teach: An apparatus according to claim 14. Orlandi does not mention wherein the sampling port comprises a gastight septum.
Olsson teaches wherein the sampling port comprises a gastight septum (page 5, lines 1-5). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the apparatus to include wherein the sampling port comprises a gastight septum as the substitution of one type of sampling port for another would have yielded predictable results to one of ordinary skill.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Orlandi in view of Olsson in view of Lemme (US 2009/0211202 A1).
Regarding Claim 12, Orlandi in view of Olsson teach: An apparatus according to claim 1, but do not mention wherein at least one of the two closures comprises a vacuum stopper.
Lemme teaches that a vacuum stopper can create a one-way valve (paragraph 0021; 0038). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the apparatus wherein at least one of the two closures comprises a vacuum stopper as the substitution of one valve type for another would have yi3elded predictable results to one of ordinary skill.
Regarding Claim 13, Orlandi in view of Olsson teach: An apparatus according to is claim 1, but do not mention wherein each of the two closures comprises a vacuum stopper.
Lemme teaches that a vacuum stopper can create a one-way valve (paragraph 0021; 0038). It would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the apparatus wherein each of the two closures comprises a vacuum stopper as the substitution of one valve type for another would have yi3elded predictable results to one of ordinary skill.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
O’Brien et al. US 2019/0110714 A1 – paragraph 0194 mentions a taper to promote laminar flow
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY B SHAH whose telephone number is (571)272-0686. The examiner can normally be reached M-F 8-5.
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JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791