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 SEQ ID NO: 1 (peptide 2d(J3)) and SARS-COV-2 in the reply filed on 2/2/26 is acknowledged. The Applicants did not provide a reason or arguments for the traversal.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-9 are pending.
Claims 3, 7 and 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claim 1-2, 4-6 and 8 read on the elected species and are under consideration.
Claim Objections
Claim 1 is objected to because of the following informalities: “…containing the amino acid sequence…” should be amended to “comprising the amino acid sequence…”.
Claim 2 is objected to because of the following informalities: “Seq. Id. No.” should be amended to “SEQ ID NO:”.
Claim 2 is objected to because of the following informalities: “…characterized in that it has a sequence selected from Seq. Id. No. 1-5” should be amended to “wherein the amino acid sequence is selected from the group consisting of SEQ ID NO: 1, 2, 3 , 4 and 5”.
Claims 4 and 6 are objected to because of the following informalities: there is an extra space between “COVID” and “19”.
Appropriate correction is required.
Drawings
The drawings are objected to because Fig. 2-8 are blurry and illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-2, 4-6 and 8 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims 1-2, 4-6 and 8 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below and is based on the analysis presented in the USPTO’s 2019 Revised Patent subject matter Eligibility Guidance (referred to as 2019 PEG) published January 2019 and the “PEG update” in October 2019.
Claim Interpretation
Claims 1 is drawn to a peptide containing the amino acid of the formula. Claim 2 is drawn to the peptide of claim 1, wherein the sequence is selected from SEQ ID NO: 1-5. Claim 4 is drawn to the peptide of claim 1 for pharmaceutical or diagnostic use in the treatment of COVID-19. Claim 5 is drawn to the peptide of claim1 for pharmaceutical or diagnostic use in the treatment or prevention of infections caused by SARS CoV-2 or viruses with high sequence similarity to the SARS CoV virus genome. Claim 6 is drawn to the peptide of claim 2 for pharmaceutical or diagnostic use in the treatment of COVID-19. Claim 8 is drawn to the peptide of claim 2 for pharmaceutical or diagnostic use in the treatment or prevention of infections caused by SARS CoV-2 or viruses with high sequence similarity to the SARS CoV virus genome.
Subject Matter Eligibility Test for Products and Processes
Step 1: Is the claim to a process, machine, manufacture, or composition of matter (see, e.g., 79 FR 74621)?
Yes, the instant claims are directed to a statutory patent-eligible subject matter category, namely a composition of matter.
Step 2A (1): Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (see, e.g., 79 FR 74621)?
Yes, the claims are directed to a natural phenomenon, a peptide that is a fragment of a naturally occurring protein. As evidenced by GenBank AAM90673 (accessed 4/13/26), SEQ ID NO : 1 and the formula of claim 1 is a fragment of the naturally occurring surface protein Sdrl from Staphylococcus saprophyticus (see residues 590-595). Accordingly, the pending claims are directed to a naturally occurring product.
Step 2A (2): Does the Claim recite additional Elements that integrate the judicial Exception into a Practical Application?
No, the claim does not recite additional elements that integrate the judicial exception into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception (see, e.g., 79 FR 74621)?
No, the claims do not recite additional elements that amount to significantly more than the judicial exception. As indicated above, the claimed formula and peptides are fragments of a naturally occurring protein. The intended use in claims 4-6 and 8 do not amount to significantly more.
Factors for determining if the claim directed to a product of nature, as a whole, recites something significantly more than the judicial exception, are provided in the Guidance (74623; see esp. 79 FR 74623 at §I.A.3.b). see also, 79 FR.
In sum, when the relevant considerations are analyzed, they weigh against a significant difference. Accordingly, claims 1-2, 4-6 and 8 do not qualify as eligible subject matter.
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.
Claim 1-2, 4-6 and 8 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Scope of the claimed genus
Claim 1 is drawn to a peptide containing the amino acid of the formula. Claim 2 is drawn to the peptide of claim 1, wherein the sequence is selected from SEQ ID NO: 1-5. Claim 4 is drawn to the peptide of claim 1 for pharmaceutical or diagnostic use in the treatment of COVID-19. Claim 5 is drawn to the peptide of claim1 for pharmaceutical or diagnostic use in the treatment or prevention of infections caused by SARS CoV-2 or viruses with high sequence similarity to the SARS CoV virus genome. Claim 6 is drawn to the peptide of claim 2 for pharmaceutical or diagnostic use in the treatment of COVID-19. Claim 8 is drawn to the peptide of claim 2 for pharmaceutical or diagnostic use in the treatment or prevention of infections caused by SARS CoV-2 or viruses with high sequence similarity to the SARS CoV virus genome.
The USPTO provides claim terms with broadest reasonable interpretation in light of the specification. The instant specification states [PGPUB0022]:
A known amino acid derivative is understood to mean any modified amino acid residue. Examples of such known modifications are those that occur naturally (post-translational) or by synthetic modifications such as (but not limited to) phosphorylation, glycosylation, hydroxylation, methylation, sulfonylation.
The instant specification does not specifically define a “derivative” of the peptide. The instant specification states [PGPUB0024]:
Any pharmaceutically acceptable derivative of the peptide of the invention may also be used according to the invention, especially salts or complexes thereof.
Assessment of whether species are support in the original specification
Seven embodiment of the invention of the claims were reduced to practice at the time of filing. Applicants disclosed SEQ ID NOs: 1-5 and J3.4 and J3.5 (see Table 1 on p. 6 of specification).
There was no disclosure of other peptide sequences that meet the limitations of the formula of claim 1 and had the claimed functions of pharmaceutical and diagnostic use in the treatment or prevention of COVID-19 or infections caused by SARS CoV-2 or viruses with high sequence similarity to SARS-CoV-2. There was no disclosure of derivatives or complexes of the claimed peptides.
There was no disclosure of derivatives that meet the limitations of the formula of claim 1 and had the claimed functions of pharmaceutical and diagnostic use in the treatment or prevention of COVID-19 or infections caused by SARS CoV-2 or viruses with high sequence similarity to SARS-CoV-2.
Assessment of whether disclosed species are representative of the claimed genus
MPEP § 2163 states that a “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
In the instant case, the disclosure of SEQ ID NO: 1-5, J3.4 and J3.5 is not representative of the genus. The disclosure of the sequences are not representative of the entire genus encompassed by the formula of claim 1 and derivatives is large. A search of the formula resulted in over 9.4 million protein or peptide sequences that meet the structural limitations of the claim (not including derivatives). Importantly, certain claimed peptides do not appear to differ from control conditions (Fig. 9 and 10). Therefore, peptides that meets the structural limitations of the claims do not seem to have the claimed function (see Fig. 9, J3.2 (SEQ ID NO: 4) and J3.3 (SEQ ID NO: 5).
Therefore, disclosure of SEQ ID NO: 1-5, J3.4 and J3.5 are not representative of the genus of formula I and derivatives of the peptide.
Identifying characteristics and structure/function correlation
In the absence of a reduction to practice of a representative number of species, the written description requirement for a claimed genus may be satisfied by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. To meet this requirement in the instant case, the specification must describe the structural, physical and/or chemical properties of the peptide that leads to the claimed function of a pharmaceutical or diagnostic use in the treatment or prevention of COVID-19 or infections caused by SARS CoV-2 or highly similar viruses. The data do not suggest the physical basis for the claimed activity and therefore do not describe which substitutions, deletions or additions could be made while creating a derivative and preserving the claimed function.
For these reasons, the skilled artisan would not reasonably conclude that the inventor(s), at the time the application was filed, had possession of the full scope of the claimed invention.
Claims 1-2, 4-6 and 8 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. The claims and specification are not enabled for pharmaceutical or diagnostic use for the treatment and prevention of COVID-19 or for treatment and prevention of infections caused by SARS CoV-2 or viruses with high sequence similarity to SARS CoV-2 virus genome.
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 1 is drawn to a peptide containing the amino acid of the formula. Claim 2 is drawn to the peptide of claim 1, wherein the sequence is selected from SEQ ID NO: 1-5. Claim 4 is drawn to the peptide of claim 1 for pharmaceutical or diagnostic use in the treatment of COVID-19. Claim 5 is drawn to the peptide of claim1 for pharmaceutical or diagnostic use in the treatment or prevention of infections caused by SARS CoV-2 or viruses with high sequence similarity to the SARS CoV virus genome. Claim 6 is drawn to the peptide of claim 2 for pharmaceutical or diagnostic use in the treatment of COVID-19. Claim 8 is drawn to the peptide of claim 2 for pharmaceutical or diagnostic use in the treatment or prevention of infections caused by SARS CoV-2 or viruses with high sequence similarity to the SARS CoV virus genome.
(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). In view of this rule, the claims are drawn to the use of the formula of claim 1 for the pharmaceutical treatment and prevention of COVID-19, diagnosis of COVID-19, the pharmaceutical treatment and prevention of infections caused by SARS CoV-2 or viruses with high sequence similarity thereto. The claims are extremely broad because they encompass diagnosing, treating and preventing COVID-19 and treating and preventing infections caused by SARS CoV-2 or viruses with high sequence similarity. The broadest reasonable interpretation of the claims include diagnosing, treating and preventing secondary infections caused by SARS CoV-2 and related viruses.
(3) The state of the prior art and (5) The predictability or unpredictability of the art
The art recognized approaches to combatting COVID-19 include vaccines and therapeutics. The CDC (<Benefits of Getting Vaccinated | Covid | CDC> June 2025) teaches that the COVID-19 vaccine helps protect from severe illness, hospitalization and death. It should be noted that even clinically developed COVID-19 vaccines supported by extensive development and human data, does not provide complete protection against infection in all individuals. The vaccine reduced the risk of infection and reduced severity of disease, hospitalizations and death.
The Journal of Infection (Letter to the Editor, Journal of Infection 84 (2022) e116-e117) states:
A relevant aspect of this study regards secondary infections. From our analysis, it emerged that, of all the patients, 65% had positive cultures and, of these, 80% had a negative clinical outcome. Based on the data in the literature, the percentage of the COVID- 19 patients with secondary infections is highly variable, ranging between 14% and 100%, also depending on the different inclusion criteria used 7 . Differences in the population, specimen source, and the isolated pathogens are likely responsible for the wide variations reported 8 . We observed a higher incidence of secondary infections compared to that reported in the paper of Lansbury et al. 1 and other studies 2-4 , 7-8 . This discrepancy may be because we included all the positive cultures, not distinguishing between contamination, colonization and infection. In both groups, a high percentage of Coagulase-Negative Staphylococci (CoNS) was isolated. However, an important aspect to be considered is the logistical conditions in which the healthcare personnel had to work in the considered period, in which there was a rapid and sudden increase in COVID-19 cases and ICU admissions. In fact, during these pan- demic peaks, the ICU capacity of the hospital had to be increased by 300% to accommodate all patients requiring critical care.
Therefore, it would be highly unpredictable and require undue experimentation to determine in the peptides of claim 1 would have the ability to diagnose, treat and prevent COVID-19 and to treat and prevent infections caused by SARS CoV-2 and related viruses.
It is noted that pharmaceutical and biological art is generally unpredictable, requiring each embodiment to be individually assessed for physiological activity. 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.
Therefore, a person of ordinary skill in the art would not see that the in vitro data (in vitro inhibition of RBD-ACE2 interaction) by specific peptides would enable across the full scope of the claims. It would be highly unlikely and require undue experimentation that a peptide would be able to diagnose, treat and prevent COVID-19 and infections caused by SARS CoV-2 or other highly sequence related viruses.
(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). The skill in the art high with respect to physicians and scientists is generally high. However, given that SARS CoV-2 is a relatively recent and evolving virus, the art is not highly predictable.
(6) The amount of direction or guidance presented (by the inventor) and (7) The presence or absence of working examples
Applicants provide limited in vitro data of RBD-ACE2 inhibition for a small subset of peptides, without statistical analysis. Certain claimed peptides do not appear to differ from control conditions (Fig. 9 and 10). Applicants did not provide in vitro or in vivo data for diagnosis, treating or preventing COVID-19, infections caused by SARS CoV-2 and related viruses with the peptides or derivatives of the instant claims.
The data is not reasonably predictive of activity across the full scope of the claimed genus.
(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, and the specification, prior art or instant disclosure does not provide support for this.
In conclusion, the instant claims are not enabled.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4-6 and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite because it is unclear what amino acid is meant by “He” and “Gin”. “He” and “Gin” are not a recognized amino acid codes.
Claim 1 is indefinite because the phrase "preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The term “known derivative” and “derivative” in claim 1 rendered its scope unclear, since it is not known to the skilled reader which structure are intended to be encompassed by this term. Such as term includes compounds from another compound by a chemical reaction (including compounds which are structurally remote from the starting material), functional derivatives (such as compounds, wherein heteroatoms are exchanged by alternative atoms), compounds with numerous different types of side groups etc. However, there is no clear definition in the application to which extent the compounds might be modified while still being regarded as derivatives. This has the effect that the person skilled in the art cannot decide clearly which compounds are to be covered by said claim and which are not.
Claims 4-6 and 8 are indefinite because the phrase "especially” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The term “with high sequence similarity” in claim 5 and 8 is a relative term which renders the claim indefinite. The term “high sequence similarity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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, 4-6 and 8 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Sakinc et al. (Infection and Immunity, aug. 2006, p. 4615-4623, cited on the IDS).
Please note that the transitional phrase “containing” (claim 1) and “has” (claim 2) are interpreted as open. MPEP 2111.03 states the transitional term “comprising”, which is synonymous with “including,” “containing,” or “characterized by,” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Because the instant specification fails to provide a limiting definition of the phrases, the broadest reasonable interpretation of the claims include sequences in which the formula and SEQ ID NO: 1-5 are embedded and does not exclude additional, unrecited elements.
With respect to claim 1, Sakinc et al. teach the sequence of SdrI, which comprises instantly claimed formula, wherein A1 is D, A2 is Y X is G, X is N, A3 is H and X is E (DYGNHE)(residues 590-595 of the sequence on p. 4618).
With respect to claim 2, Sakinc et al. teach the sequence comprises DYGNHE at residues 590-595, which is identical to instantly claimed SEQ ID NO: 1.
With respect to claims 4-6 and 8, the limitations “for pharmaceutical or diagnostic use…” and “for use in the treatment…” is regarded at the intended use of the composition or product will and does not further limit claims drawn to a composition or product. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In Re Hack 114, USPQ 161. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim limitation. In the instant case, the sequence from Sakinc et al. meets the structural limitations of the instant claims.
Conclusion
No claims are allowed.
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.
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/TARA L MARTINEZ/Examiner, Art Unit 1654
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