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 .
Specification
The disclosure is objected to because of the following informalities:
“Medicament” is misspelled in paragraph [0012].
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: “medicament” is misspelled in line 1 of the claim. Appropriate correction is required.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-9 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
With respect to Claim 1, the claim recites the following phrases that positively recite the fetus of parts thereof as part of the system:
Line 1: “a system providing a medicament to a fetus”
Lines 9-12:” wherein the fetus has an umbilical cord comprising a vein, a first artery, and a second artery; wherein the umbilical cord of the fetus is connected to the second fluid circuit using a plurality of cannulae comprising a first cannula to a vein of the umbilical cord, attaching a second cannula to a first artery of the umbilical cord, attaching a third cannula to a second artery of the umbilical cord”
Lines 13-17: “wherein at least one of the cannulae is in fluid connection with the fetus's circulatory system and the umbilical cord is connected to the oxygenator such that deoxygenated blood is delivered from the fetus to the oxygenator, and oxygenated blood is delivered from the oxygenator to the fetus”
The examiner recommends amending these clauses to use “configured to” language (i.e. “a system configured to provide a medicament to a fetus,” etc.)
Claims 2-9 are rejected because they depend from claim 1.
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 Flake (US 2019/0380900).
With respect to Claim 1, Flake teaches a system providing a medicament to a fetus (see Abstract; paragraphs [0073]-[0074], [0079], [0097], [0099], [0115], and especially [0125]; figures 5-6, 27, 31), comprising:
a chamber 100 having an interior space 102 configured to enclose the fetus 2;
a first fluid circuit 300 that delivers sterile fluid to the chamber, the first fluid circuit including a source 304 of a liquid 302, a pump 312 configured to move the fluid from the source to the chamber and deliver the fluid from the chamber to a reservoir 306 (paragraphs 0097-0099]);
a second fluid system 400 including an oxygenator 60 configured to transfer oxygen to the fetus (Figure 31; paragraphs [0115-0118]);
wherein the fetus has an umbilical cord 4 including two arteries and one vein;
wherein the umbilical cord of the fetus is connected to a plurality of cannulae 140 comprising: a first cannula attached to the vein of the umbilical cord, a second cannula attached to a first artery of the umbilical cord, and a third cannula attached to a second artery of the umbilical cord, and the one or more of the first, second, and third cannulae are connected to an oxygenation circuit, which includes the oxygenator paragraphs [0073]-[0074], [0079], [0097], [0099], [0115], and [0125]; figures 5-6, 11, 27, 31);
wherein each of the cannulae is in fluid connection with the circulatory system of the fetus, and the umbilical cord is connected to the oxygenator by the cannulae such that deoxygenated blood is delivered from the fetus to the oxygenator, and oxygenated blood is delivered from the oxygenator to the fetus (paragraphs [0073]-[0074], [0079], [0097], [0099], [0115], especially [0125]; figures 5-6, 27, 31); and
wherein the second fluid circuit may include one or more ports (442) which may be used to inject or infuse medicine or nutrition directly into the blood (see claim 32 of the PGPub; paragraphs [0073]-[0074], [0079], [0097], [0099], [0115], and especially [0125]; figures 5-6, 27, 31).
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 8 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Flake (US 2019/0380900).
With respect to Claim 8, Flake teaches the system of claim 1, wherein medicament is introduced through a port 442. Figure 31 indicates ports 442 as being disposed both upstream and/or downstream of the oxygenator 60 (Figure 31; Paragraph [0125]).
In the event that Applicant does not clearly envisage this interpretation, the examiner notes that there is a finite number of predictable solutions for the location of the medicament port(s) (either upstream of the oxygenator or downstream of the dialyzer), each with a reasonable expectation of success. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to try modifying Flake’s system to have the medicament port disposed downstream of the oxygenator, because doing so would be one of a limited number of possible locations for said port, and one of ordinary skill I the art would have arrived at a downstream configuration through routine experimentation with a reasonable expectation of success.
Claim 2-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Flake (US 2019/0380900) in view of Flake (“A Supportive Physiologic Environment for the Extreme Premature Infant: Improving Life Outside the Womb”; Journal of Pediatric Surgery, 02-2022, Vol. 57, No. 2, pp. 167-171; provided by applicant in an IDS; hereinafter referred to as Journal of Pediatric Surgery).
With respect to Claims 2 and 3, Flake teaches the system of Claim 1, but does not specifically teach that the medicament is at least one of stem cells and modified genes. However, Journal of Pediatric Surgery teaches a similar extracorporeal, extrauterine system for newborn development, the system having a sterile fluid environment, an oxygenator circuit, and an umbilical/vascular interface (the “EXTEND system”; see Abstract and entire disclosure), wherein the system provides means for single or repeated administration of stem cells, gene vectors, or pharmacologic agents to the patient (see Figure 1 and the “Potential Clinical Applications of EXTEND” section). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Flake’s system for providing medicaments to a fetus to provide stem cells and/or gene therapy via modified genes, as suggested by Journal of Pediatric Surgery, in order to provide means for supplying the premature infant with stem cell therapy and/or gene therapy, and because these therapies are known in the art.
With respect to Claims 4-7 and 9, Flake and Journal of Pediatric Surgery reasonably suggest the system of Claim 2, but are silent as to the specific types of stem cells or genes administered. However, the examiner takes official notice that all of the treatments required in Claims 3-7 and 9 are extraordinarily well known in the field of stem cell and gene therapy. Specifically, therapy using allogenic stem cells, autologous stem cells, tolerogenic stem cells, genetically modified autologous stem cells, and modified genes are all well known in the arts of stem cell and gene therapies. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify the system of Flake and Journal of Pediatric Surgery to provide one or more of allogenic stem cells, autologous stem cells, tolerogenic stem cells, genetically modified autologous stem cells, and modified genes as the applied medicament, because these treatments are all well-known types of stem cell therapy and gene therapy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sitzmann (US 2007/0010005), Fassihi (US 2019/0209408), Fassihi (US 2017/0128322), Flake (US 2016/0022524), and Matsubara (US 2013/0274543) teach a neonatal support system comprising an oxygenator.
Heidaran (US 2013/0259845) teaches treatment of premature birth complications using stem cells.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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, Sarah Al-Hashimi can be reached at (571) 272-7159. 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.
/PHILIP R WIEST/ Primary Examiner, Art Unit 3781
Prosecution Insights