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 Status
Claims 1-20 are currently pending in this application.
Election/Restrictions
Applicant’s election with traverse of the species having a portable and pressurized oxygen source in the reply filed on July 29, 2026 is acknowledged. Upon further consideration, the restriction requirement as set forth in the Office action mailed on 6/29/26 is hereby WITHDRAWN. As the elected species of generic claim 11 and 17 is considered allowable and all species were fully examined for patentability without serious burden, the species election requirement is withdrawn. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) are: (1) “providing energy to effect” the pumping; and (2) “configured to generate and compress oxygen in response to a chemical reaction within the portable oxygen source.”
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(d)
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 10 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 10 limits the moving of the mixture into the vasculature and the regulating of the pressure of the mixture to being performed by a single device (i.e., the same device). However claim 1 already required the pumping of the mixture and regulating of the pressure of the mixture to be effectuated by a single device. Thus, claim 10 fails to further limit the subject matter of 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 § 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6 and 10 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Hassanein (US 20150342177 A1, IDS ref.).
Regarding claims 1 and 10, Hassanein discloses a perfusion system to preserve tissue (an organ), the system comprising: a portable oxygen source (172) ([0184]-[0185]) to simultaneously provide oxygen and to apply a pressure gradient to a flow of the oxygen to form an oxygenated perfusion fluid (perfusate mixture) ([0005]; [0009]; [0408]); and having an inlet fluidly coupled to vasculature of the tissue (interface) (162, 166, 170) ([0331]; [0007]) housed in an organ chamber (104) ([0249]); and an oxygen line to fluidly coupled to the portable oxygen source to the organ preservation system via an inlet (308) ([0144]-[0145]); “gas in” FIG. 17), wherein the oxygen source applies the pressure gradient to pump fluid containing the oxygen (perfusate) through the system and the tissue ([0017]; FIG. 3A; [0005]; [0009]), representing a way of using a portable oxygen source to provide energy to help push the mixture through the system, i.e., “effect pumping.” The entire system described above qualifies or could be interpreted as a “single device” under a broadest reasonable interpretation of the term. Further, Hassanein expressly states the single device with the oxygen source both provides and regulates a pressure for the system to effectuating a pumping.
Regarding claim 2, Hassanein discloses the portable oxygen source may pump the fluid in a continuous output mode (continuously) ([0286]).
Regarding claims 3-4, Hassanein discloses the portable oxygen source is to pump the fluid in a pulsed output mode (pulsatile fashion) ([0286]; [0290]), such as via rotating a pumping screw in a variable fashion to produce a cyclical pumping rate ([0235]).
Regarding claim 5, as mentioned above, Hassanein discloses the oxygen source is a portable source (172) configured to provide gaseous oxygen to the fluid perfusate flowing through the organ preservation system ([0184]).
Regarding claim 6, Hassanein discloses wherein the system comprises a portable oxygen concentrator ([0184]).
Regarding claim 10, Hassanein anticipates claim 10 by virtue of anticipating claim 1 as set forth above as claim 10 fails to further limit the invention of claim 1.
Thus, Hassanein anticipates the claimed invention.
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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hassanein in view of Long (US20200023105A1, published Jan. 2020).
As set forth fully above, Hassanein anticipates claims 1-6 and 10, and, thus, renders obvious the subject matter of claims 1-6 and 10.
Regarding claims 7 and 9, Hassanein does not expressly teach the oxygen source comprises an oxygen generator, such as using a chemical reaction operating within the oxygen source device.
However, Long teaches a method of providing oxygenated fluid to a tissue wherein oxygen is provided via an oxygen generator ([0032]), including an oxygen generator generating oxygen via one or more chemical reactions, i.e., chemical oxygen generator ([0032]). Thus, it would have been prima facie obvious to one of ordinary skill in the art at the effective time of filing to modify the method taught by Hassanein to include an oxygen generator, such as a chemical oxygen generator, as taught by Long. One of ordinary skill in the art would be motivated to use any oxygen source commonly used in the prior art to oxygenate a liquid intended for circulation through a living tissue, including using an oxygen generator known in the prior art and specifically a chemical oxygen generator as taught by Long.
Regarding claim 8, Hassanein does not expressly teach the oxygen source comprises a pressure swing adsorption system.
However, Hassanein teaches a portable oxygen concentrator ([0184]), and Long teaches a method of providing an oxygenated fluid to a tissue wherein oxygen is concentrated using a pressure swing adsorption process, such as using the Oxysure™ or Airsep Focus Portable Oxygen Concentrator ([0033]). Thus, it would have been prima facie obvious to one of ordinary skill in the art at the effective time of filing to modify the oxygen concentrator taught by Hassanein to specifically being one of the type known in the art as taught by Long for use in an art-recognized process to function in an art-recognized purpose and further to minimize energy consumption by this medical device.
Regarding claim 9, Hassanein does not expressly teach the portable oxygen source generates and compresses oxygen in response to a chemical reaction within.
Thus, the claimed invention as a whole is prima facie obvious in the absence of evidence to the contrary.
Allowable Subject Matter
Claims 11-20 are allowed. The closest prior art, Hassanein (US20150342177A1), does not teach or reasonably suggest the method wherein a pump is powered by the oxygen source itself, such as via pressurized oxygen released from the oxygen source. Instead, the prior art teaches wherein a portable oxygen source device provides oxygen under pressure to help push an oxygenated perfusate fluid through the system and wherein the oxygen source pressure may be regulated, but not wherein any actual pump is powered by the oxygen source itself.
Conclusion
Claims 1-10 stand rejected, and claims 11-20 are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC J ROGERS whose telephone number is (571)272-8338. The examiner can normally be reached Monday - Friday 9:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached on (571) 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC J ROGERS/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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