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 .
Claim Objections
Claim 1 is objected to because of the following informalities: Line 1 reading “Ternary phased” should read --A ternary phased--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Lines 2-3 reading “an individual, herein known as “the patient” or “patient”,” should read --a patient--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 5 reading “a patient” should read --the patient--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Lines 6-7 reading “a respiratory system” should read --the respiratory system--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 9 reading “a viral pathogen” should read --the viral pathogen--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Lines 10-12 recite the limitation “comprised of: at least one (1) continuous aqueous suspension, at least (1) medical device, at least one (1) medical theater, at least one (1) central computer, at least one (1) computerized device, at least one (1) network and comprised of at least the steps of” should read --comprised of: at least one continuous aqueous suspension, at least one medical device, at least one medical theater, at least one central computer, at least one computerized device, at least one network and comprised of at least the steps of--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 14 reading “a MP” should read --the MP--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 15 reading “a MP” should read --the MP--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 16 reading “a viral pathogen” should read --the viral pathogen--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 17 reading “a MP” should read --the MP--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 17 reading “a medical examination” should read --the medical examination--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 19 reading “a MP” should read --the MP--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 19 reading “a medical examination” should read --the medical examination--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Lines 20-21 reading “a lipid membrane” should read --the lipid membrane--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 22 reading “a MP” should read --the MP--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 22 reading “a medical procedure” should read --the medical procedure--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 24 reading “a MP” should read --the MP--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 26 reading “a MP” should read --the MP--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 27 reading “an MCC” should read --a Microcrystalline Castile Colloid (MCC)--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 28 reading “a medical device(s)” should read --the medical device--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 30 reading “a MP” should read --the MP--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 32 reading “a MP” should read --the MP--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 32 reading “a medical theater” should read --the medical theater--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Line 1 reading “A step of claim 1 of performing by a MP” should read --The ternary phased medical procedural process of claim 1 comprising--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Line 2 reading “a medical procedure” should read --the medical procedure--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Line 7 reading “a MP” should read --the MP--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Line 9 reading “a MP” should read --the MP--. Appropriate correction is required. 31. Claim 3 is objected to because of the following informalities: Line 11 reading “a Microcrystalline Castile Colloid (MCC)” should read --the MCC--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Line 14 reading “a MP” should read --the MP--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Line 15 reading “the chest” should read --a chest--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Line 18 reading “a MP” should read --the MP--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Line 18 reading “a cleansing of the patient’s target lung” should now read --the cleansing of a target lung of the patient--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Lines 20-23 reading “chest percussions and pre-determined casual order and volume metrics as pre-determined a MP” should read --the chest percussions and the pre-determined casual order and volume metrics a pre-determined by the MP--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Line 23 reading “a MP” should read --the MP--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Line 23 reading “a viral pathogen lipid’s membrane” should read --the lipid membrane of the viral pathogen--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Lines 25-26 reading “a pre- determined casual order and volume metrics” should read --the pre-determined casual order and volume metrics--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Line 28 reading “a MP” should read --the MP--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Line 29 reading “the patient’s target lung” should read --the target lung of the patient--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Line 31 reading “a MP” should read --the MP--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Line 32 reading “the patient’s target lung” should read --the target lung of the patient--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Line 34 reading “a MP” should read --the MP--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Line 35 reading “an MCC in an external vessel” should read --the MCC in the external vessel--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Lines 36-37 reading “a viral pathogen” should read --the viral pathogen--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Line 38 reading “a MP” should read --the MP--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Line 39 reading “a MCC in an external vessel” should read --the MCC in an external vessel--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Lines 40-41 reading “unencapsulated RNA of a viral pathogen” should read --the unencapsulated RNA of the viral pathogen--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Line 42 reading “a MP” should read --the MP--. Appropriate correction is required. Claim Rejections - 35 USC § 101
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 recites the limitation “Ternary phased medical procedural process for fracturing and cleansing a viral pathogen from a respiratory system of an individual, herein known as “the patient” or “patient”, by a ternary phased medical procedural performed by a Medical Professional (MP), consisting of at least; reviewing a medical history of the patient, diagnosing a patient as positive for a viral pathogen, determining that the viral pathogen is encapsulated by a lipid membrane, determining the viral pathogen is infecting a respiratory system of the patient, selecting a medical device of the medical procedure, prepping the patient for the medical procedure, performing a procedure upon the patient, diagnosing the patient as negative for a viral pathogen, rehabilitating the patient and following-up post procedure the patient's status.” This recited concept and steps recited thereafter is being deemed an abstract idea because the recited steps are merely a thought process without detail for the apparatuses carrying them out. For instance, the selection of a medical device does not appear to be made for any particular reason based on the information gathered. Finally, it is unclear how information is being gathered and how it is being utilized. Gathering medical information on a computing device is not in and of itself novel.
This judicial exception is not integrated into a practical application because applicant’s reciting of actual structure for carrying out the invention, at least one medical device, at least one medical theater, at least one central computer, and at least one computerized device do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea via a generic medical device and a generic computer in a generic medical setting. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the selecting of a medical device is not in any way connected to the viral pathogen. Therefore, the selecting of a medical device appears to be completely at random without any input from data that has been gathered. Furthermore, the elements of at least one computerized device and at least one network appear merely for storing and retrieving information in memory. Such well- understood, routine, conventional computer functions are recognized by court decisions listed in MPEP § 2106.05(d) as providing no inventive step. Claim 3 is rejected by virtue of its dependence on Claim 1. Appropriate correction and/or clarification is required.
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 and 3 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 lists a number of steps to be taken in the ternary phased medical procedural. A number of these steps is listed at the beginning of the claim, “reviewing a medical history of the patient, diagnosing a patient as positive for a viral pathogen, determining that the viral pathogen is encapsulated by a lipid membrane, determining the viral pathogen is infecting a respiratory system of the patient, selecting a medical device of the medical procedure, prepping the patient for the medical procedure, performing a procedure upon the patient, diagnosing the patient as negative for a viral pathogen, rehabilitating the patient and following-up post procedure the patient’s status.” Any number of these steps is repeated in Lines 14-35 of Claim 1. It is unclear if applicant is inadvertently repeating these steps in the claim or is intending that these steps are to be repeated by the MP. Claim 3 is rejected by virtue of its dependence on Claim 1. Appropriate correction and/or clarification is required.
Claims 1 and 3 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 Line 4 reads “a Medical Professional (MP).” Thereafter, applicant refers to “an MP” through the claims. It is unclear whether applicant is referring to the same MP or a different MP as first recited in Line 4 of Claim 1. For purposes of examination, all iterations of “MP” are being considered to refer back to the first iteration of MP recited in Line 4 of Claim 1. Claim 3 is rejected by virtue of its dependence on Claim 1. Appropriate correction and/or clarification is required.
Claims 1 and 3 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 Line 4 reads “consisting of at least.” It is unclear whether applicant is attempting to use the transitional phrase “consisting of” or some other type transitional phrase. Transitional phrases and their use is covered by MPEP 2111.03. For purposes of examination, the term “consisting of at least” is being treated as “consisting of.” Claim 3 is rejected by virtue of its dependence on Claim 1. Appropriate correction and/or clarification is required.
Claims 1 and 3 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 Lines 7-8 recites the limitation “selecting a medical device of the medical procedure, prepping the patient for the medical procedure, performing a procedure upon the patient.” There is insufficient antecedent basis for the term “the medical procedure” of Line 7 of the claim. Furthermore, it is unclear whether the term “a procedure” is the same procedure as first described in Line 7, i.e., “the medical procedure.” For purposes of examination, all recitations of procedure are being treated as the procedure first recited in Line 7. Claim 3 is rejected by virtue of its dependence on Claim 1. Appropriate correction and/or clarification is required.
Claims 1 and 3 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 recites the limitation "the network" in Line 35. There is insufficient antecedent basis for this limitation in the claim. Claim 3 is rejected by virtue of its dependence on Claim 1. Appropriate correction and/or clarification is required.
Claim 3 is 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. Lines 1-2 of Claim 3 recite the limitation “a ternary medical procedure.” It is unclear what the relationship of this term is to “Ternary phased medical procedural process” in Line 1 of Claim 1 and “ternary phased medical procedural” in Line 3 of Claim 1. The present case is being interpreted where these are all the same processes. Appropriate correction and/or clarification is required.
Claim 3 is 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 3 recites the limitation " the MD/S (nPk) x ELT (nPk) endotracheal lumen" in Lines 9-10. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction and/or clarification is required.
Claim 3 is 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. Lines 10-11 recite the limitation “a continuous aqueous transport medium.” It is unclear if this is the same solution as first described in Lines 10-11 of Claim 1 reading “at least one (1) continuous aqueous suspension.” These two solutions are being treated as the same for purposes of examination. Appropriate correction and/or clarification is required.
Claim 3 is 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. Lines 14-17 of Claim 3 read as follows: “performing, by a MP, manual chest percussions and/or mechanized chest percussion on the chest of the patient for a duration of time consistent with a pre-determined casual order and volume metrics as determined by a step of claim 1.” It is unclear what step is being referenced to in Claim 1. Appropriate correction and/or clarification is required.
Claim 3 is 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. Lines 23-27 of Claim 3 reads as follows: determining, by a MP, a viral pathogen lipid's membrane is fractured by the MCC, manual chest percussions and/or mechanized chest percussion on the chest of the patient for a duration of time consistent with a pre-determined casual order and volume metrics as determined by a step of claim 1, and its unencapsulated RNA is freely suspended within the MCC.” It is unclear what step is being referenced to in Claim 1. Appropriate correction and/or clarification is required.
Claim 3 is 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. Lines 32-33 recite the limitation “a continuous aqueous therapeutic solution.” It is unclear if this is the same solution as first described in Lines 10-11 of Claim 1 reading “at least one (1) continuous aqueous suspension.” These two solutions are being treated as the same for purposes of examination. Appropriate correction and/or clarification is required.
Claim 3 is 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. Lines 34-37 recite the limitation “determining, by a MP, utilizing a visualization and/or medical device that an initial volume metric of a MCC in an external vessel contains and acceptable or non-acceptable concentration of unencapsulated RNA of a viral pathogen.” It is unclear what “a visualization and/or medical device” is referencing and whether this is the same medical device as previously recited throughout Claim 1. Appropriate correction and/or clarification is required.
Claim 3 is 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. Lines 38-41 recite the limitation “repeating, by a MP, as necessary, a step of a claim 1 and/or 2 until a secondary or thereafter volume metric of a MCC in an external vessel contains an acceptable concentration of unencapsulated RNA of a viral pathogen.” It is unclear what step is being referenced to in Claim 1. It is also unclear how the determination of an acceptable concentration of unencapsulated RNA is being interpreted. Furthermore, Claim 3 is referring back to Claim 2 in this limitation, a claim on which Claim 3 does not depend. Appropriate correction and/or clarification is required.
Claim 3 is 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. Lines 42-43 recite the limitation “repositioning, by a MP, the patient on the medical table, and repeating a step of claim 1 and/or claim 2 on a second lung of the patient.” There is insufficient antecedent basis for the term “the medical table” in Claim 3. It is unclear what step is being referenced to in Claim 1. Furthermore, Claim 3 is referring back to Claim 2 in this limitation, a claim on which Claim 3 does not depend. Appropriate correction and/or clarification is required.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peyman (USPGPub 2021/0228619).
Re Claim 1, Peyman teaches a ternary phased medical procedural process for fracturing and cleansing a viral pathogen from a respiratory system of an individual (Peyman Abstract; ¶ 0634-0636, 0728, 0733), herein known as “the patient” or “patient”, by a ternary phased medical procedural performed by a Medical Professional (MP), consisting of at least; reviewing a medical history of the patient (Peyman ¶ 0796-0800), diagnosing a patient as positive for a viral pathogen, determining that the viral pathogen is encapsulated by a lipid membrane (Peyman ¶ 0796-0800 - wherein influenza and COVID viruses are encapsulated by lipid membranes), determining the viral pathogen is infecting a respiratory system of the patient (Peyman ¶ 0796-0800 - wherein influenza and COVID viruses infect the respiratory system), selecting a medical device of the medical procedure (Peyman ¶ 0634 - inhaler or nebulizer), prepping the patient for the medical procedure, performing a procedure upon the patient, diagnosing the patient as negative for a viral pathogen, rehabilitating the patient and following- up post procedure the patient’s status; comprised of: at least one (1) continuous aqueous suspension, at least (1) medical device, at least one (1) medical theater, at least one (1) central computer, at least one (1) computerized device, at least one (1) network and comprised of at least the steps of: a) reviewing, by a MP, a medical history of the patient (Peyman ¶ 0796- 0800); b) diagnosing, by a MP, as a result of conducting a medical examination upon the patient, the patient’s infectious status as positive for a viral pathogen; c) diagnosing, by a MP as a result of conducting a medical examination, that the viral pathogen is infecting the patient’s respiratory system; d) determining, by a MP as a result of conducting a medical examination, that ribonucleic acids (RNA) of the viral pathogen are encapsulated by a lipid membrane (Peyman ¶ 0796-0800 - wherein influenza and COVID viruses are encapsulated by lipid membranes); e) determining, by a MP, a medical procedure to eliminate the viral pathogen from the respiratory system of the patient (Peyman Abstract; ¶ 0634-0636, 0728, 0733); f) determining, by a MP, a causative order of the steps of the medical procedure; g) determining, by a MP, from a diagnostic reading a volume metric concentration of an MCC, an air flow rate, an interval, a pressurization, a manual or machine percussion duration, a utilization of a medical device(s), a volume metric of a suspension(s), and a duration of the medical procedure (Peyman ¶ 0043); h) programming, by a MP, a computerized device to process a medical data of the medical procedure; and i) equipping, by a MP, a medical theater with network connectivity means, a Central Computer equipped with a Non-Transitory Computer Readable Medium Database, (CCNTCRMD) a computerized device and connecting the central computer to the network (Peyman ¶ 0796-0800).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Peyman (USPGPub 2021/0228619) in view of Hummer et al. (USPGPub 2022/0365066) and above, and further in view of McCathy et al. (USPGPub 2023/0233750).
Re Claim 3, Peyman teaches all of the limitations of Claim 1. Peyman further teaches performing by the MP, a secondary phase of a ternary medical procedure upon the patient comprising a) determining, by the MP, a vital sign of the patient is in a range and monitoring a vital sign of the patient during the medical procedure (Peyman ¶ 0796-0800); c) performing, by the MP, manual chest percussions and/or mechanized chest percussion on the chest of the patient for a duration of time consistent with a pre-determined casual order and volume metrics as determined by a step of claim 1 (Peyman ¶ 0043); e) the manual chest percussions and/or mechanized chest percussion on the chest of the patient for a duration of time consistent with a pre-determined casual order and volume metrics as determined by a step of claim 1 (Peyman ¶ 0043 — ventilator).
However, Peyman fails to teach a medical procedure upon the patient that fractures the lipid membrane encapsulating the viral pathogen that is infecting the patient’s respiratory system, a continuous aqueous transport medium of a Microcrystalline Castile Colloid (MCC), of a semi-homogeneous amalgam of a modestly hydrophobic and highly lipophilic profile; e) determining, by the MP, a viral pathogen lipid’s membrane is fractured by the MCC, and its unencapsulated RNA is freely suspended within the MCC; h) determining, by the MP, utilizing a visualization and/or medical device that an initial volume metric of a MCC in an external vessel contains and acceptable or non-acceptable concentration of unencapsulated RNA of a viral pathogen.
Hummer teaches a medical procedure that fractures a lipid membrane encapsulating a viral pathogen that is infecting a patient’s respiratory system (Hummer ¶ 0131), the procedure further comprising the steps of: e) determining, by the MP, a viral pathogen lipid’s membrane is fractured by the MCC, and its unencapsulated RNA is freely suspended within the MCC (Hummer ¶ 0131-0132); h) determining, by the MP, utilizing a visualization and/or medical device that an initial volume metric of a MCC in an external vessel contains and acceptable or non-acceptable concentration of unencapsulated RNA of a viral pathogen (Hummer Fig. 58; ¶ 0131, 0279), the lysing procedure for deactivating the viral particles.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included in the medical procedure of Peyman to include fracturing the lipid membrane encapsulating the viral pathogen that is infecting the patient’s respiratory system, a continuous aqueous transport medium of a Microcrystalline Castile Colloid (MCC), of a semi-homogeneous amalgam of a modestly hydrophobic and highly lipophilic profile; e) determining, by the MP, a viral pathogen lipid’s membrane is fractured by the MCC, and its unencapsulated RNA is freely suspended within the
MCC; h) determining, by the MP, utilizing a visualization and/or medical device that an initial volume metric of a MCC in an external vessel contains and acceptable or non-acceptable concentration of unencapsulated RNA of a viral pathogen as disclosed by Hummer, the lysing procedure for deactivating the viral particles.
Peyman in view of Hummer fail to teach cleansing the fractured lipid membrane and the unencapsulated RNA of the viral pathogen from the patient’s respiratory system and rehabilitating the patient further comprising the steps of: b) introducing, by the MP, through a MD/S (nPk) x ELT (nPk) endotracheal lumen and into an elevated side lung cavity of the patient; d) performing, by the MP, a cleansing of the patient’s target lung by fracturing the lipid membrane of the viral pathogen and the un-encapsulating the RNA of the viral pathogen of the viral pathogen by utilizing the MCC, chest percussions and pre-determined casual order and volume metrics as pre-determined the MP; f) draining, by the MP, the MCC, inclusive of the viral pathogen’s unencapsulated RNA, out of the patient’s target lung and into an external vessel; g) rinsing, by the MP, the MCC, inclusive of the viral pathogen’s unencapsulated RNA, out of the patient’s target lung and into an external vessel utilizing a continuous aqueous therapeutic solution; i) repeating, by the MP, as necessary, a step of a claim 1 until a secondary or thereafter volume metric of a MCC in an external vessel contains an acceptable concentration of unencapsulated RNA of a viral pathogen; and j) repositioning, by the MP, the patient on the medical table, and repeating a step of claim 1 on a second lung of the patient.
McCathy teaches performing a medical procedure on a patient’s respiratory system comprising introduction of an endotracheal tube into an elevated side lung cavity of the patient (McCathy ¶ 0002, 0038; Fig. 1); d) performing, by the MP, a cleansing of the patient’s target lung, chest percussions and pre-determined casual order (McCathy ¶ 0035 — ventilator); f) draining, by the MP, fluid out of the patient’s target lung and into an external vessel (McCathy ¶ 0111; Fig. 7B); g) rinsing, by the MP, debris out of the patient’s target lung and into an external vessel utilizing a continuous aqueous therapeutic solution (McCathy ¶ 0111; Fig. 7B); i) repeating, by the MP, as necessary, a step of a claim 1 until a secondary or thereafter volume metric of a MCC in an external vessel contains an acceptable concentration of unencapsulated RNA of a viral pathogen; and j) repositioning, by the MP, the patient on the medical table, and repeating a step of claim 1 on a second lung of the patient, the procedure for preventing the formation of biofilms in the lungs (McCathy ¶ 0038).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included in the medical procedure of Peyman in view of Hummer cleansing the fractured lipid membrane and the unencapsulated RNA of the viral pathogen from the patient’s respiratory system and rehabilitating the patient further comprising the steps of: b) introducing, by the MP, through a MD/S (nPk) x ELT (nPk) endotracheal lumen and into an elevated side lung cavity of the patient; d) performing, by the MP, a cleansing of the patient’s target lung by fracturing the lipid membrane of the viral pathogen and the un-encapsulating the RNA of the viral pathogen of the viral pathogen by utilizing the MCC, chest percussions and pre-determined casual order and volume metrics as pre-determined the MP; f) draining, by the MP, the MCC, inclusive of the viral pathogen’s unencapsulated RNA, out of the patient’s target lung and into an external vessel; g) rinsing, by the MP, the MCC, inclusive of the viral pathogen’s unencapsulated RNA, out of the patient’s target lung and into an external vessel utilizing a continuous aqueous therapeutic solution; i)
repeating, by the MP, as necessary, a step of a claim 1 until a secondary or thereafter volume metric of a MCC in an external vessel contains an acceptable concentration of unencapsulated RNA of a viral pathogen; and j) repositioning, by the MP, the patient on the medical table, and repeating a step of claim 1 on a second lung of the patient, similarly as disclosed by McCathy for preventing the formation of biofilms in the lungs (McCathy ¶ 0038).
Response to Arguments
Applicant's arguments filed 07/31/2024 have been fully considered but they are not persuasive. Applicant’s arguments directed to 101 rejections begin at the bottom of Page 1 of the response. There, applicant argues “revised claims now clearly outline each step of the process with specific details on how the steps are performed, demonstrating a practical application, and moving beyond a mere abstract idea.” However, applicant’s only amendments to the claims were to change “pulmonary system” to “respiratory system.” Arguments directed to 112 indefinite rejections begin near the top of Page 2 of the response. Examiner has provided guidance on how 112 indefinite rejections can be corrected in the rejections above. Examiner recommends that claims in the present case be changed in the manner suggested by examiner.
On Page 2 of the response, applicant requests rejoinder of withdrawn claims. Rejoinder is applicable when a base claim upon which a withdrawn claim is dependent is made allowable. In such a circumstance, examiner will be rejoining withdrawn claims. In the last paragraph of Page 2 of the response, applicant states:
The applicant has amended the claims in accordance with the examiner's recommendations for the purpose of ensuring clarity, specificity, and consistency. The present amendments are consistent with the examiner's recommendations and distinguish the claimed invention from the cited prior art, focusing on the novel aspects and non- obvious improvements. The amendments are provided for the purpose of distinguishing the claimed invention from the cited prior art, focusing on the novel aspects and non-obvious improvements that would not be made by one who is ordinarily skilled in the field of endeavor to which the present invention pertains.
None of the recommendations made by the examiner have been made. All claim objections and 112 indefinite rejections remain outstanding. Applicant’s amendments of “MP” in Claims 1 and 3 appear only to further introduce indefiniteness into the claims.
Under the header “Non-Obviousness Improvements” header, applicant argues “The cited art of references does not suggest this specific combination of steps, nor do they provide motivation to combine these steps in view of the innovation of the present invention.” This argument fails to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. At the top of Page 4 of the response, applicant alleges reliance on primary reference Peyman “is highly speculative in nature.” This is not a legal standard upon which an anticipation rejection can be overturned. In particular, applicant states prior art Peyman fails to teach MCC. Applicant argues the claimed invention uses a MCC to fracture a lipid membrane of a viral pathogen. However, fracturing a lipid membrane is not recited in Claim 1, upon which Peyman was relied to anticipate.
Near the bottom of Page 4 of the response, applicant argues prior art Peyman fails to teach selection of a medical device. Said limitation is not patentable subject matter. In the final paragraph of Page 4 of the response, applicant argues Hummer fails to teach the use of MCC for suspending unencapsulated RNA. However, applicant does not claim MCC for suspending unencapsulated RNA. The top of Page 5 of the response are directed to secondary reference McCarthy. Applicant argues McCarthy fails to teach “a ternary phased medical procedure for viral pathogen cleansing.” However, McCarthy explicitly teaches a medical procedure for viral pathogen cleansing (McCathy ¶ 0002, 0038; Fig. 1).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783