DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ response to the Requirement for Restriction, filed 14 January 2026, in the matter of Application N° 17/614,107. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 10-13 have been canceled. No claims have been added.
None of the remaining claims has been amended.
No new matter has been added.
Applicants’ election of Group I (claims 1-9 and 14-20), without traverse, is acknowledged.
Applicants’ election is made FINAL. The claims of Groups: II and III (claims 10-13) are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim. Applicants timely traversed the restriction requirement between the composition and method.
Thus, claims 1-9 and 14-20 are presented and represent all claims currently under consideration.
Information Disclosure Statement
Two Information Disclosure Statements (IDS) filed 24 November 2021 and 3 May 2024 is acknowledged and has been considered.
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 1-9 and 14-20 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to laws of nature and natural phenomena without significantly more.
The claims recite laws of nature and natural phenomena. These judicial exceptions are not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception as explained below:
Subject Matter Eligibility Guidance
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP §2106:
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Step (1): Is the claim directed to a process, machine, manufacture, or composition of matter?
Step (2A): Is the claim directed to a law of nature, natural phenomenon (product of nature), or an abstract idea?
Prong 1 – Does the claim recite a law of nature, natural phenomenon, or an
abstract idea?
Prong 2 – If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application?
Limitations that are indicative of integration into a practical application include:
Improvements to the functioning of a computer, or to any other technology or technical field. See MPEP §2106.05(a)
Applying the judicial exception with, or by use of, a particular machine. See MPEP §2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing. See MPEP §2106.05(c)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. See MPEP §2106.05(d)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. See MPEP §2106.05(e)
Step (2B): If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly different than the judicial exception such that they provide an inventive concept? This step includes evaluation of the same considerations under Step (2A), Prong 2, as well as two additional considerations:
Adding a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; and
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Analysis
Step (1): The answer to this step is yes since claims 1-9 and 14-20 are directed to a composition of matter, which is a statutory category.
Step (2A): The answer to this step is yes because the claimed compositions are directed to laws of nature and natural phenomena, specifically naturally occurring metabolites, found, for instance in, human suction blister fluid.
Prong 1:
Product of Nature Definition
When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a “product of nature.” See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979.
Claim Analysis
Independent claim 1 recites “[a] pharmaceutical composition for prophylaxis and/or treatment of a pathological condition with decreased lung compliance, comprising a polyamine.”
Independent claim 8 recites “[a]medical solution for washing pulmonary alveoli, comprising a polyamine.”
[emphases added to reflect intended use limitations]
The Examiner acknowledges that the composition is styled in the preambles as being a “pharmaceutical” composition or “medical” solution. However, the scope of the positively recited elements of the composition defines it in terms of naturally-occurring compounds, and as such the compositions are defined as comprising of naturally-occurring polyamine compounds. Therefore, the instant claim recites a product of nature.
Dependent claim 2 recites a limitation which only serves to further define the intended use, and thus remains drawn to a naturally-occurring polyamine composition.
Dependent claims 3-5, 9, and 14-16 recite naturally-occurring polyamine derivatives (e.g., acetylspermidine).
Dependent claims 6, 7, and 17-20 recite that the compositions of claims 1 and 8 further comprise a phospholipid. Claim 7 recites phospholipid species.
There is no evidence within the specification that the compositions recited in claims 1-9 and 14-20 contain markedly different characteristics from their naturally-occurring counterparts.
Therefore, the answer to step 2A prong 1 is yes.
Prong 2:
The Prong Two analysis considers the claim as a whole. That is, the limitations containing the judicial exception as well as the additional elements in the claim besides the judicial exception need to be evaluated together to determine whether the claim integrates the judicial exception into a practical application.
Here, the instantly claimed compositions do not introduce any additional limitations which transform or improve on the judicial exceptions recited in claims 1-9 and 14-20 and do not do anything beyond generally linking the use of the judicial exception to a particular technological environment.
Therefore, the answer to step 2A prong 2 is no.
Step (2B):
Claims 1-9 and 14-20 do not recite additional elements which require analysis under step 2B.
At most, claims recite that the compositions comprising species of polyamines and phospholipids.
The state of the art additionally recognizes that naturally-occurring metabolites such as spermidine, acetylspermidine, and phospholipids (e.g., Table 1) as disclosed by Niedzwiecki et al. (Analytical Chemistry; 2018), are naturally-occurring metabolites found within human suction blister fluid.
Therefore, compositions comprising the instantly claimed ingredients, notably in solution form, or as “pharmaceutical” or “medicinal” compositions, are well-understood as possessing routine, and conventional activity.
Therefore, the answer to step (2B) is no.
Conclusion
Claims 1-9 and 14-20 are directed to a judicial exception and do not qualify as eligible subject matter under 35 U.S.C. §101.
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.
(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 1-3, 8, 9, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et al. (KR 20180049691 A; IDS/ISR reference cited).
The instantly elected invention is directed to a composition comprising a polyamine. The limitations recited in claim whereby the composition is “for prophylaxis and/or treatment of a pathological condition with decrease lung compliance” is considered by the Examiner as being directed to one of intended use and is not considered to contribute to the overall patentability of the claimed invention. The same interpretation is set forth for claim 2 whereby the condition is limited to ARDS. As such, claim 2 is considered to recite the same compositional limitations as claim 1.
Park discloses a pharmaceutical composition comprising spermidine (see e.g., pg. 1, lines 11-13). The reference additionally discloses a food composition comprising spermidine (see pg. 1, lines 26-28). The “food” is further defined as being embodied by a liquid composition, such as a beverage or tea (see e.g., pg. 6, lines 227-230).
The foregoing is considered to expressly meet the instantly claimed invention.
Claims 1-3, 6-9, 14, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) being anticipated by Lin et al. (CN 107094755 A; machine translation attached and cited).
The instantly elected invention is directed to a composition comprising a polyamine. The limitations recited in claim whereby the composition is “for prophylaxis and/or treatment of a pathological condition with decrease lung compliance” is considered by the Examiner as being directed to one of intended use and is not considered to contribute to the overall patentability of the claimed invention. The same interpretation is set forth for claim 2 whereby the condition is limited to ARDS. As such, claim 2 is considered to recite the same compositional limitations as claim 1.
Claim 6 recites that the composition further comprises a phospholipid. Claim 7 further defines the phospholipid.
Lin discloses a nutritional cryopreservation diluent comprising spermine and spermidine (polyamines), as well as glycerol and soy lecithin and egg lecithin (see e.g., claims 1-3). As defined by the state of the art, lecithin is being a complex mixture of acetone-insoluble phosphatides comprising phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine, and phosphatidylinositol (see e.g., Handbook of Pharmaceutical Excipients; 2009).
The reference is thus considered to expressly meet each of the instantly recited limitations.
Claims 1-3, 5-9, 16, 18, and 20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) being anticipated by Tan et al. (USPN 8,795,644 B2).
The instantly elected invention is directed to a composition comprising a polyamine. The limitations recited in claim whereby the composition is “for prophylaxis and/or treatment of a pathological condition with decrease lung compliance” is considered by the Examiner as being directed to one of intended use and is not considered to contribute to the overall patentability of the claimed invention. The same interpretation is set forth for claim 2 whereby the condition is limited to ARDS. As such, claim 2 is considered to recite the same compositional limitations as claim 1.
Tan discloses a method of lifting color of keratinous substrates, comprising applying onto said substrates a composition in a cosmetically acceptable medium, comprising such ingredients as: at least one phospholipid (component (a)), and at least one alkaline agent (component (f)) (see e.g., claim 1).
Claim 2 further limits the phospholipid component to lecithin. As discussed above, lecithin is defined by the state of the art as being a complex mixture of acetone-insoluble phosphatides comprising phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine, and phosphatidylinositol (see e.g., Handbook of Pharmaceutical Excipients; 2009).
Claim 11 further defines component (f) as being organic amines, which are further defined in the reference as being embodied by such compounds as: 1,3-diaminopropane, spermine, and spermidine (see e.g., col. 8, lines 1-17).
The foregoing is thus considered to expressly meet the instantly claimed compositional limitations.
Claims 1-4, 6-9, and 14-19 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) being anticipated by Niedzwiecki et al. (Analytical Chemistry; 2018).
The instantly elected invention is directed to a composition comprising a polyamine. The limitations recited in claim whereby the composition is “for prophylaxis and/or treatment of a pathological condition with decrease lung compliance” is considered by the Examiner as being directed to one of intended use and is not considered to contribute to the overall patentability of the claimed invention. The same interpretation is set forth for claim 2 whereby the condition is limited to ARDS. As such, claim 2 is considered to recite the same compositional limitations as claim 1.
Claim 8 recites a solution comprising a polyamine.
Niedzwiecki discloses the characterization of a metabolome (i.e., complete set of small-molecule chemicals, or metabolites, present in a biological sample) of human suction blister fluid, which largely consists of interstitial fluid (ISF) collected from 10 human volunteers (see e.g., Abstract). Table 1 lists the metabolites found in elevated SBF and includes both phospholipids and spermidine. The characterized putative compounds include: glycerophosphocholine, glycerylphosphorylethanolamine, phosphoethanolamine, and multiple phosphatidylinositols. The spermidine is characterized as both spermidine and acetylspermidine.
Owing that the aforementioned metabolites are found naturally within human SBF, the Examiner further submits that the “solution” limitation is also met.
The foregoing disclosure is thus considered to expressly meet the limitations of the instantly claimed composition.
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615