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 .
Election/Restrictions
Applicant's election with traverse of asthma in the reply filed on 6/29/26 is acknowledged. The traversal is on the ground(s) that asthma is basically the same as that of any of the other identified inflammatory lung disease. Applicants also argue that any prior art searched for one group is applicable to the other group and there is no serious search burden.
This argument was persuasive and the election of species requirement is withdrawn.
Claims 1-20 are pending and under consideration.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 should be amended to “A composition comprising a surfactant protein A (SP-A) peptide analogue , wherein the SP-A peptide analogue is a purified peptide comprising Ac-WGKEQCVE(Nle)(Pego3)-Hdc (SEQ ID NO: 24).
Claims 11 and 14 are objected to because of the following informalities: Claims 11 and 14 should be amended to “…wherein the inflammatory lung disease is selected from the group consisting of asthma, chronic obstructive pulmonary disease (COPD) and COVID-19”.
Claim 12 is objected to because of the following informalities: Claim 12 should be amended to “…administering a therapeutically effective amount of the composition according to claim 1..”
Claim 13 is objected to because of the following informalities: Claim 13 should be amended to “…comprising the amino acid sequence of Ac-WGKEQCVE(Nle)(Pego3)-Hdc (SEQ ID NO: 24).
Claim 15 is objected to because of the following informalities: Claim 15 should be amended to “…and asthma associated with infections”.
Claim 20 is objected to because of the following informalities: Claim 20 should be amended to “…comprising the amino acid sequence of Ac-WGKEQCVE(Nle)(Pego3)-Hdc (SEQ ID NO: 24).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. As stated in MPEP 2164.01(a), “there are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.”
The factors to be considered when determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, were described in In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) as:
1. the nature of the invention;
2. the breadth of the claims;
3. the state of the prior art;
4. the relative skill of those in the art;
5. the predictability or unpredictability of the art;
6. the amount of direction or guidance presented [by the inventor];
7. the presence or absence of working examples; and
8. the quantity of experimentation necessary [to make and/or use the invention.
(1) The Nature of the Invention
Claim 7 is drawn to a method of enhancing SP-A activity in a cell with SEQ ID NO: 24. Claims 12 and 13 are drawn to a method of treating or preventing an inflammatory lung disease in a subject with SEQ ID NO: 24. Claim14 is drawn to the inflammatory lung disease is asthma, COPD or COVID-19.
(2) The Breadth of the claims
The claims will be given its broadest reasonable interpretation. The applicable rule for interpreting the claims is that “each claim must be separately analyzed and given its broadest reasonable interpretation in light of and consistent with the written description.” See MPEP 2163(II)(1), citing In re Morris, 127 F.3d 1048, 1053-1054; 44 USPQ2d 1023, 1027 (Fed. Cir. 1997). The instant specification defines “inflammatory lung disease” [PGPUB0067]: As used herein, an “inflammatory lung disease” refers to any lung disease with high levels of inflammation where leukocytes, including neutrophils and eosinophils, are the predominant immune cell infiltrating the lung. Inflammatory diseases may include but are not limited to asthma, chronic obstructive pulmonary disease (COPD), acute respiratory distress syndrome (ARDS), Coronavirus disease (COVID, e.g., COVID-19), and other respiratory infections.
Therefore, the broadest reasonable interpretation of the claims includes preventing and treating all inflammatory lung diseases, such as COVID-19 and all respiratory infections.
(3) The state of the prior art
The state of the art is there is no single agent that prevents and treats all inflammatory lung disease. Katamesh et al. (Pharmacological Reports (2025) 77:889-906) teaches that inflammatory lung disease including COPD, asthma, pulmonary sarcoidosis and interstitial lung diseases (ILDs) represents a significant cause or morbidity and mortality globally (Abstract). Katamesh et al. teach that the underlying etiology of inflammatory lung diseases is multifactorial, involving a complex interplay between genetic predisposition, environmental exposures to injurious stimuli and an over-reactive immune response (p. 890, bottom of 2nd col.). Katamesh et al. states:
“Genetic susceptibility plays a role, with variations in genes like Interleukin 33 (IL33) and Ormdl sphingo lipid biosynthesis regulator 3 (ORMDL3) linked to asthma, Butyrophilin-like protein 2 (BTNL2) and Major Histocompatibility Complex, Class II, DR Beta 1 (HLA-DRB1) associated with sarcoidosis, and telomerase reverse transcriptase (TERT) mutations implicated in idiopathic pulmonary fibrosis (IPF) [11, 15, 17, 18, 27, 28]. Environmental factors, including smoking, allergens, pollutants, occupational exposures, and infections, act as triggers or exacerbate symptoms in genetically predisposed individuals.” And
“The management of inflammatory lung diseases involving both pharmacological and non-pharmacological interventions is tailored according to the type of disease, symptoms, and case severity, as well as the extent of organ involvement.”
Therefore, Katamesh et al. teach that there are genetic factors and environmental factors at play in inflammatory lung disease and management involved both pharmacological and non-pharmacological interventions. Katamesh et al. does not teach prevention of the diseases as a whole. There was no teaching in Katamesh et al. that all inflammatory lung diseases could be prevented or treated.
Healthline (<Medications for Lung Inflammation> 10/13/21) teaches lung inflammation can happen with infection, injury and harmful substances. Healthline states that lung inflammation can happen from infectious causes such as bacteria, fungi or viruses or as a type of allergic reaction. Importantly, Healthline teaches that treatment of lung inflammation varies based on the cause of inflammation: acute or chronic and the severity. Some examples of medications include: antibiotics to treat bacterial pneumonia, antifungals to treat lung infections cause by fungi, corticosteroids to reduce inflammation, bronchodilators that help relax the airway, leukotriene modifiers to limit of block the effects of leukotrienes etc.
Therefore, there is no one treatment known in the art for treatment and prevention of all inflammatory lung diseases. Furthermore, it is highly unlikely and would require undue experimentation to determine if the peptide would be able to prevent or treat all inflammatory lung diseases. For example, bacterial pneumonia that requires antibiotics to control the infection. It would be unlikely that SEQ ID NO: 24 would be able to treat inflammatory lung diseases caused by infections.
Therefore, the state of the art at the time of the application is that the etiology and treatment/prevention of inflammatory lung diseases is not well understood and therapy is challenging and complex. Adding to the complexity are the many different diseases encompassed by the “inflammatory lung diseases”.
(4) The relative skill of those in the art
MPEP 2141.03 states (in part)” A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727, 167 LEd2d 705, 82 USPQ2d 1385, 1397 (2007). “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At 1396, 82 USPQ2d at 1396. The “hypothetical person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988) (disagreeing with the examiner’s definition of one of ordinary skill in the art (i.e. a doctorate level engineer or scientist working at least 40 hours per week in semiconductor research or development), and finding that the hypothetical person is not definable by way of credentials, and that the evidence in the application did not support the conclusion that such a person would require a doctorate or equivalent knowledge in science or engineering). In the instant case, the skill in the art high with respect to physicians and scientists. The level of skill in the art (physicians and scientists) would be high.
(5) The predictability or unpredictability of the art
It is noted that pharmaceutical and biological art is generally unpredictable, requiring each embodiment to be individually assessed for physiological activity. Furthermore, the claimed “inflammatory lung diseases” are different diseases with distinct etiologies and pathologies. Given this fact, historically the development of new drugs has been difficult and time-consuming. Adding to the unpredictability is that many treatment options may show promise in animal models, but may fail to show therapeutic improvement in clinical trials. There is no absolute predictability, even in view of the high level of skill in the art.
Thus, it would be highly unpredictable given the art and the breadth of the claims to determine if the peptide could treat and prevent all inflammatory lung diseases.
(6) The amount of direction or guidance presented (by the inventor) and (7) The presence or absence of working examples
The applicant did not provide sufficient guidance or direction regarding the potential treatment or prevention of all inflammatory diseases. There was no data presented for SEQ ID NO: 24.
Applicants disclose SEQ ID NO: 8 (20mer) in HDM model (dust mite model). SEQ ID NO: 8, 2, 3 and 4 could reduce mucin production in the HDH model. SEQ ID NO: 4 is 65% identical to instantly claimed SEQ ID NO: 24. SEQ ID NO: 3 is 20% identical to instantly claimed SEQ ID NO: 24. SEQ ID NO: 2 is 63% identical to instantly claimed SEQ ID NO: 24 (Ex. 1-3). Applicants disclose that full length SP-A and the 20mer binds to ACE2 (Ex. 5). Full length SP-A is 248 amino acids in length, therefore the results using full length SP-A cannot be extrapolated to the 9-mer (SEQ ID NO: 24).
The instant specification did not provide data that one of ordinary skill in the art could reasonable expect SEQ ID NO: 24 could treat or prevent lung infections or COPD or other lung inflammatory diseases.
Therefore, the specification and working examples provided by the applicant do not support treatment and prevention of lung inflammatory diseases with SEQ ID NO: 24.
(8) The quantity of experimentation necessary (to make and/or use the invention)
Owing to the factors listed above, especially in points 6 and 7, the amount of experimentation needed will be extensive in view of the lack of guidance by the inventor. MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
The instant breadth of the claim is broader than the disclosure, specifically, the instant claims are directed to the treatment and prevention of all inflammatory lung diseases, however the specification, prior art or instant disclosure does not provide support for this. In particular, the specification demonstrates some activity for the tested peptides in the specification. SEQ ID NO: 24 only shares approx. 64% sequence identity with those peptides and one of ordinary skill in the art would not reasonably expect the biological properties of the tested peptides to be predictive of SEQ ID NO: 24 in the absence of supporting experimental data.
Allowable Subject Matter
Claim 1 and 20 (and dependent claims 2-6) are objected to, however, the claims include allowable subject matter. There was no prior art found that teaches or suggests the peptide of SEQ ID NO: 24. The closest prior art is USPN 11,110,152. The USPN claims a method of delivering SEQ ID NO: 4 to a lung cell in a subject, wherein said delivering results in one or more of enhancing SP-A activity in the cell and treating asthma. However, SEQ ID NO: 4 is only 65% identical to instantly claimed SEQ ID NO: 24. There was no teaching of suggestion to modify SEQ ID NO: 4 to arrive at SEQ ID NO: 24. Therefore, the peptide is novel.
Conclusion
Claim 1-6 and 20 are objected.
Claims 7-19 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TARA L MARTINEZ whose telephone number is (571)270-1470. The examiner can normally be reached Mon-Fri 8:00-5:00.
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, Lianko Garyu can be reached at (571)270-7367. 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.
/TARA L MARTINEZ/Primary Examiner, Art Unit 1654
Prosecution Insights