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 .
DETAILED ACTION
Claim Status
The amendment on May 12, 2026 is acknowledged. Claims 1-6, 8-13 are currently pending. Claim 7 is canceled. Claims 4-5, 11-13 have been amended. Claims 8-13 have been withdrawn. Claims 1-6 will be examined on the merits herein.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-8 in reply filed on May 12, 2026 is acknowledged. Claims 8, 9-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
Acknowledgment is made of applicant’s claim for foreign priority based on application filed on May 20, 2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement (IDS)
Accordingly, the information disclosure statement is being considered by the examiner.
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 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
The claims recite a composition for inhalation to treat respiratory syncytial virus comprising “a polyclonal antibody derived from human breastmilk, wherein the composition comprises intact antibodies representing more than about 81% of total antibodies, the total antibodies comprising the intact antibodies and degraded antibodies”. This judicial exception is not integrated into a practical application because the claims are directed to a composition which is a product of nature. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations in the claims are either additional statements characterizing the product of nature (claims 1-4, 5-6) or are recitations of intended use (claims 1, 4). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements recited.
(MPEP 2106.04(b)(II)):
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". For example, the isolated DNA of Myriad and the primers of Ambry Genetics were described as products of nature by the courts. 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 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281 (1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and "phenomena of nature"). Step 2A of the Office’s eligibility analysis uses the terms "law of nature" and "natural phenomenon" as inclusive of "products of nature".
Regarding Step 1 of the analysis, the claims are directed to the statutory category of a product.
Regarding Step 2A, prong one, the claims are directed to and recite the judicial exception of a nature-based product. The claims are directed to “a composition for inhalation to treat respiratory syncytial virus comprising “a polyclonal antibody derived from human breastmilk, wherein the composition comprises intact antibodies representing more than about 81% of total antibodies, the total antibodies comprising the intact antibodies and degraded antibodies”. However, a polyclonal antibody derived from human breastmilk is natural product found in animals, including human subjects. The specification at page 5 states that that the process combine biochemical and analytical techniques to extract maternal antibodies from the breastmilk of mammals, including humans (see lines 3-5). The specification also states at page 5 that the process of extraction of maternal antibodies begins with the collection of breastmilk from a mammalian donor. Breastmilk may be expressed from the breast by using physical stimulation, a mechanical pump apparatus, a combination of these, or any other method that stimulates the flow of breastmilk from the milk duct. The process may involve collecting the sample, transporting the sample via refrigeration, and processing the milk into the formulation for inhalation soon after collection (see lines 16-22). Therefore, a composition that comprises “a polyclonal antibody derived from human breastmilk is a product of nature. “Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U. S. 63, 67 (1972). Therefore, the claims encompass a nature-based product/product of nature, which is a judicial exception.
Regarding Step 2A, prong two, having determined that the claims recite a judicial exception, it is then determined whether the claims recite additional elements that integrate the judicial exception into a practical application. The claims do not recite any additional elements.
Regarding Step 2B, the next question is whether the remaining elements/steps – i.e., the non-patent-ineligible elements/steps – either in isolation or combination, amount to significantly more than the judicial exception. Here, the claims as a whole are not considered to recite any additional steps or elements that amount to significantly more and do not add something “significantly more” so as to render the claims patent-eligible because while claims 1, 4 recite an intended use, this intended use does not further limit the subject matter of the claim.
Lueangsakulthai et al. (Survival of recombinant monoclonal and naturally-occurring human milk immunoglobulins A and G specific to respiratory syncytial virus F protein across simulated human infant gastrointestinal digestion. J Funct Foods. 2020 Oct; 73:104115. doi: 10.1016/j.jff.2020.104115) provides evidence that anti-RSV polyclonal IgG and sIgA/IgA derived from human milk are naturally occurring products (see Figure 2 at page 5; Figure 3 at page 6).
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 (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 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.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lueangsakulthai et al. (Published August 25, 2020; hereafter Sah; PTO-892) in view of Mane (Pat. US 11124560 B2; hereafter Mane; PTO-892).
As claims 1-3. Lueangsakulthai teaches that human milk contains RSV-specific IgG, IgA and sIgA that can neutralize RSV.
Lueangsakulthai teaches that naturally-occurring human milk RSV F protein-specific polyclonal IgG and sIgA/IgA were stable across the gastric phase of digestion.
Lueangsakulthai teaches that naturally-occurring RSV F protein-specific human milk polyclonal IgG and sIgA/IgA were more stable across ex vivo gastrointestinal digestion than palivizumab IgG, IgA and sIgA.
Lueangsakulthai teaches that naturally-occurring human milk anti-RSV IgG and sIgA/IgA antibodies were more resistant to degradation than monoclonal antibodies.
Lueangsakulthai teaches that naturally-occurring antibodies may have greater resistance to digestion because of their differing structures compared with the structures of recombinant antibodies.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Lueangsakulthai et al. (Published August 25, 2020; hereafter Sah; PTO-892) as applied to claims 1-3 above, in view of Larios Mora et al. (Published 2018; hereafter Larios Mora; PTO-892).
Lueangsakulthai teaches the limitations of claims 1-3 as fully discussed above and incorporated herein.
However, Lueangsakulthai does not teach the composition is to be nebulized for delivery as claim 4.
Larios Mora teaches that similarly to humans, lambs exhibit several key features of RSV-vaccine enhanced disease; anatomically, the respiratory tract of sheep and humans share many structural features, such as the size of the nasal cavity and airways, as well as lung development where alveolarization starts pre-term.
Larios Mora teaches that the delivery of a trivalent nanobody, ALX-0171 by inhalation greatly reduces respiratory syncytial virus disease in newborn lambs.
Larios Mora teaches that local pulmonary administration of ALX-0171 was considered optimal for this indication as it enables targeted delivery straight to the site of infection, with a potentially more rapid onset of action while using lower doses compared to systemic administration.
Larios Mora also teaches that ALX-0171 is a novel inhaled biotherapeutic in development for the treatment of RSV infections in infants.
It would be obvious to one of skill in the art to combine the teachings of Lueangsakulthai and Larios Mora, thereby arriving at the invention of claim 4. Since the human milk contains anti-RSV polyclonal antibody that can neutralize RSV as taught by Lueangsakulthai and the delivery of the trivalent nanobody, ALX-0171 by inhalation greatly reduces respiratory syncytial virus disease, it would have been obvious to substitute these known equivalents; see MPEP 2144.06.
See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.
Also, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results". In the instant case, Lueangsakulthai teaches a product (and method) that only differs from the claimed invention by the substitution of a single component (i.e. oral delivery); the substituted element (i.e. airway delivery) was already known and known to function as an effective delivery method for administration of antibodies against RSV, therefore no change in the function of the substituted element occurred; and one of ordinary skill in the art would be capable of choosing an effective method for delivery antibody, such as airway administration disclosed as being useful with a reasonable expectation of success (i.e. the substitution of the element would lead to predictable results), particularly because Lueangsakulthai teaches that human milk contains anti-RSV polyclonal antibody effective against RSV infection. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PRICILA HAUK TEODORO whose telephone number is (571) 272-2784. The examiner can normally be reached 6:15AM-3:00PM.
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/PRICILA NMN HAUK TEODORO/Examiner, Art Unit 1645
/HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684
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