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 .
This Office action is responsive to Applicant’s amendment and remarks, filed 20 March 2026, in which claims 1-2, 8, 18, and 22 are amended to change the scope and breadth of the claim, claims 3-4 are canceled, new claim 25 is added, and withdrawn claim 24 is amended.
This application is the national stage entry of PCT/EP2021/067732, filed 28 June 2021; and claims benefit of foreign priority document EP 20183323.3, filed 30 June 2020. This foreign priority document is in English.
Claims 1-2 and 5-25 are pending in the current application. Claims 23-24, drawn to non-elected inventions, are withdrawn. Claims 1-2, 5-22, and 25 are examined on the merits herein.
Objections Withdrawn
Applicant’s amendment, filed 20 March 2026, with respect that claim 18 is objected to because of informalities has been fully considered and is persuasive, as amended claim 18 does not recite the indicated informalities.
This objection has been withdrawn.
Rejections Withdrawn
Applicant’s amendment, filed 20 March 2026, with respect that claims 1-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph as not being enabling for the full scope of the claim has been fully considered and is persuasive, as claims 3-4 are canceled, and amended claims 1 and 22 do not recite the full scope of prevention of an infection with rhinovirus in a human.
This rejection has been withdrawn.
Applicant’s amendment, filed 20 March 2026, with respect that claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite has been fully considered and is persuasive, as amended claim 8 clarifies the meaning of the claim terms.
This rejection has been withdrawn.
Applicant’s remarks, filed 20 March 2026, with respect that claims 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 and 29-30 of copending Application No. 18/002,665 (reference application) has been fully considered and is persuasive, as the reference application is now abandoned.
This provisional rejection has been withdrawn.
The following are new or modified grounds of rejection necessitated by Applicant’s amendment, filed 20 March 2026, in which claims 1-2, 8, 18, and 22 are amended to change the scope and breadth of the claim, claims 3-4 are canceled, and new claim 25 is added.
Claim Rejections - 35 USC § 112
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.
Amended Claims 2, 6, 12-13, and 19-21 are 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. Claims 2-4, 6, 12-13, and 19-21 depend from claim 1, are drawn to the pharmaceutical composition, and recite further limitations of the intended method of using the claimed composition. These claims are interpreted as limiting the claimed pharmaceutical composition to those structural features of the composition implied by the recited method of use. Since none of these dependent claims impose any further meaningful structural limitation onto the pharmaceutical composition described in independent claim 1, they all fail to further limit the base claim. 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.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 20 March 2026, have been fully considered and not found to be persuasive.
Applicant notes that there is no requirement that dependent claims need to further limit the statutory category. However, MPEP 2111.04 at I. regarding “wherein” clauses provides “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.” In this case the subject matter to which the claims are drawn to is a “Pharmaceutical composition”, which falls within the statutory category (per 35 U.S.C. 101) of a manufacture or composition of matter. The subject matter to which the claims are drawn to, a “Pharmaceutical composition”, does not fall within the statutory category of a process (per 35 U.S.C. 101). Because the claim is not drawn to a process, the claim does not require steps involved in a process to be performed, such as the those related to the intended use of claimed “Pharmaceutical composition”. As detailed in the rejection of record, the dependent claims 2-4, 6, 12-13, and 19-21 recite further limitations of the intended method of using the claimed composition, but fail to impose any further meaningful structural limitation onto the pharmaceutical composition described in independent claim 1, therefore each of claims 2-4, 6, 12-13, and 19-21 fail to further limit the base claim. In this case, independent claim 1 requires the structure of a “Pharmaceutical composition” comprising fucoidan and the implied structure that it is capable of being administered intranasally to a human for the treatment or inhibition of an infection with rhinovirus. The dependent claims 2-4, 6, 12-13, and 19-21 recite further limitations of the intended method of using the claimed composition but do not further limit the particular structure of the “Pharmaceutical composition” as recited in claim 1 from which these claims depend.
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.
Amended Claims 1-2, 5-14, and 19-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alevizopoulos (WO 2015/082356 A1, published 11 June 2015, provided by Applicant in IDS filed 21 Dec 2022).
Alevizopoulos discloses ionic aqueous compositions useful as nasal passage washes for the treatment of respiratory tract and/or respiratory mucosal-related conditions. The composition includes an ionic aqueous solution and algae-derived constituents, such as branched, sulfated polysaccharides having an average molecular weight greater than 4kDa and comprising L-fucose and sulfate ester groups or extracts from brown algae (abstract). In one embodiment, the sulfated polysaccharide is derived from an extract isolated from brown algae. In another embodiment, the brown algae is Undaria pinnafitida. In another embodiment, the sulfated polysaccharide is fucoidan. In yet another embodiment, the sulfated polysaccharide is in a range of about 0.1 to about 10% weight content of the composition (page 2, lines 10-15), meeting limitations of claims 1, 9, 14, and 22. In one embodiment, the compositions include about 0.1 % to about 10% sulfated polysaccharide or fucoidan weight content of the composition, or from about 0.1 % to about 1 % weight content of the composition (page 16, lines 5-10), meeting limitations of claim 7. In other embodiments, the composition includes at least about 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1 %, 1.5%, or 2% fucoidan weight content (page 16, lines 5-10), or fucoidan in a concentration of approximately 2000 μg/ml, 3000 μg/ml, up to 20000 μg/ml, based on the density of an aqueous composition of approximately 1g/ml, meeting limitations of claim 8. In one embodiment, the ionic aqueous solution includes saline (page 3, lines 5-10), meeting limitations of claim 10. In another embodiment, the composition has an osmolarity value ranging from about 250-350 mOsm/L for isotonic (page 3, lines 10), meeting limitations of claim 11. In one embodiment, the composition is formulated for nasal administration (page 3, line 15), meeting limitations of claim 1 and 22. The composition can be applied in the form of a nasal spray (page 9, lines 5-10), meeting limitations of claim 5. By "respiratory tract and/or respiratory mucosal-related conditions," are meant any conditions or disorders with abnormal mucus production, secretion or clearance or inflammation (bacterial, viral, allergic or autoimmune) of the nasal, bronchial and pulmonary mucosa (page 5, lines 20-25). The composition can be administered as per physician's instructions, such as 1-5 sprays per nostril, 1-5 times daily (page 26, lines 20-25).
Regarding claims 1-2, 6, 12-13, and 19-22, these claims are drawn to the pharmaceutical composition and recite further limitations of the intended method of using the claimed composition. These claims are interpreted as limiting the claimed pharmaceutical composition to those structural features of the composition implied by the recited method of use. Alevizopoulos discloses the composition can be administered as per physician's instructions, such as 1-5 sprays per nostril, 1-5 times daily. Further, Alevizopoulos discloses the same fucoidan isolate from the same algae Undaria pinnafitida. This implies the composition disclosed in Alevizopoulos necessarily meets all structural limitations required of a composition that is capable of being used to perform the recited method of use. See also MPEP 2111.04 providing “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.”
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 20 March 2026, have been fully considered and not found to be fully persuasive.
Regarding claim 18 and new claim 25, Applicant’s remarks are persuasive that Alevizopoulos does not necessarily or inherently disclose the fucoidan isolated from Undaria pinnatifida described in Alevizopoulos contained a sulfate content of 29% by weight, or a sulfate content of 20% to 40% (w/w). Therefore this rejection of claim 18 is withdrawn.
Applicant remarks that Alevizopoulis fails to disclose treatment or inhibition of rhinovirus infection and the independent claims of the present application are expressly directed to compositions and methods for treating rhinovirus infection. However, the elected and examined claims are drawn to the compositions and not methods for treating rhinovirus infection. As detailed in the rejection of record, MPEP 2111.04 at I. regarding “wherein” clauses provides “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.” As detailed above, in this case the subject matter to which the claims are drawn to is a “Pharmaceutical composition”, and not a process, therefore the claim does not require steps involved in a process to be performed, such as the those related to the intended use of claimed “Pharmaceutical composition”. In this case, the examined claims requires the structure of a “Pharmaceutical composition” comprising fucoidan and the implied structure that it is capable of being administered intranasally to a human for the treatment or inhibition of an infection with rhinovirus. As detailed in the rejection of record, Alevizopoulis discloses a “Pharmaceutical composition” and all structural features as claimed in claims 1-14 and 19-22 including those implied structural features of a composition that is capable of being used according the intended use recited in the claims. Because the claims drawn to the “Pharmaceutical composition” do not require any steps of a process to be performed, and the intended use does not limit a claim to a particular structure other than those disclosed in Alevizopoulis, Alevizopoulis discloses each and every claim element which is a limitation of the claimed subject matter.
Amended Claims 1-2, 5-7, 9-10, 12-13, and 19-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grassauer et al. (WO 2009/027057 A1, published 05 March 2009, provided by Applicant in IDS filed 21 Dec 2022).
Grassauer et al. discloses the alternative of fucoidan in the form of an antiviral pharmaceutical composition for the prophylaxis or treatment of a pathological condition or disease caused by or associated with an infection by a respiratory virus (abstract). Grassauer et al. discloses a fucoidan-based composition in its ready-for-use form for topical or oral administration may comprise fucoidan in an amount of between 0.1 and 2 % weight per volume (w/v) or weight per weight (w/w). It may further comprise at least one pharmaceutically acceptable carrier and/or additive. Sodium chloride is frequently used as an additive (page 15, lines 1-10), meeting limitations of claims 1, 7, 10. The carrier may be diluent, e.g. water, saline, or phosphate-buffered saline (page 12, lines 1-5), meeting limitations of claims 9-10. Grassauer et al. discloses pharmaceutical compositions according to the invention for mucosal application include nose sprays or drops (page 10, lines 15-25), meeting limitations of claims 1 and 5. Fucoidan is usefully applied as an antiviral active ingredient in the manufacture of a pharmaceutical composition effective for the prophylaxis or treatment of pathological conditions or diseases caused by or associated with a respiratory virus infection, such as RSV (page 14, lines 30-35; example 12 at page 25, line 35 to page 26, line 10), meeting structural limitations implied in claim 22.
Regarding claims 1-4, 6, 12-13, and 19-22, these claims are drawn to the pharmaceutical composition and recite further limitations of the intended method of using the claimed composition. These claims are interpreted as limiting the claimed pharmaceutical composition to those structural features of the composition implied by the recited method of use. Grassauer et al. discloses the fucoidan in the form of an antiviral pharmaceutical composition for the prophylaxis or treatment of a pathological condition or disease caused by or associated with an infection by a respiratory virus, and explicitly discloses the intended use for the prophylaxis or treatment of RSV. This implies the composition disclosed in Grassauer et al. necessarily meets all structural limitations required of a composition that is capable of being used to perform the recited method of use. See also MPEP 2111.04 providing “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.”
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 20 March 2026, have been fully considered and not found to be fully persuasive.
Similar to Applicant’s remarks regarding Alevizopoulis above, Applicant remarks that Grassauer et al. fails to disclose treatment or inhibition of rhinovirus infection. However, the elected and examined claims are drawn to the compositions and not methods for treating rhinovirus infection. For similar reasons as detailed regarding Alevizopoulis, Grassauer et al. discloses a “Pharmaceutical composition” and all structural features as claimed in claims 1-7, 9-10, 12-13, and 19-22 including those implied structural features of a composition that is capable of being used according the intended use recited in the claims. Because the claims drawn to the “Pharmaceutical composition” do not require any steps of a process to be performed, and the intended use does not limit a claim to a particular structure other than those disclosed in Grassauer et al., Grassauer et al. discloses each and every claim element which is a limitation of the claimed subject matter.
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.
Amended Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Alevizopoulos (WO 2015/082356 A1, published 11 June 2015, provided by Applicant in IDS filed 21 Dec 2022).
Alevizopoulos discloses as above as applied to amended claims 1-2, 5-14, and 19-22. Alevizopoulos further teaches the sulfated polysaccharides are generally from about 4 kDa to about 5 MDa, including 50, 70, 90, 100, 300 kDa or an average molecular weight in between these particular sizes (page 15, line 25). In one embodiment, the extracts are filtered to separate fractions of different sizes. The filtration can be performed using ultra filtration filters having different molecular weight cutoffs (page 18, line 30 to page 19, line 5).
Alevizopoulos does not specifically disclose the fucoidan has an average molecular weight from 50 kDa to 120 kDa, determined by size exclusion chromatography, with a mobile phase comprising 150 mM NaCl and having pH 6. (claim 15) Alevizopoulos does not specifically disclose the fucoidan has an average molecular weight of 150 kDa and a lower molecular weight cut-off of 10 kDa. (claim 17)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the molecular weight of the fucoidan from within the teachings of Alevizopoulos. One of ordinary skill in the art would have been motivated to select the molecular weight of the fucoidan with a reasonable expectation of success because Alevizopoulos teaches the sulfated polysaccharides are generally from about 4 kDa to about 5 MDa such as 50, 70, 90, 100, 300 kDa, or in between these values, and teaches it was known to separate fractions of different sizes or different molecular weight cutoffs. Regarding the determination by size exclusion chromatography having a particular mobile phase, it would have been obvious to one of ordinary skill in the art that the molecular weight of a compound would have been expected to be the same and not dependent on a particular method of determining that molecular weight.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 20 March 2026, have been fully considered and not found to be fully persuasive.
Applicant’s remarks regarding Alevizopoulis and the intended use of the claimed “Pharmaceutical composition” are addressed above.
Applicant’s remarks that the scope of disclosure of Alevizopoulis encompasses a range of molecular weights for the sulfated polysaccharides. However, Alevizopoulis in itself provides guidance for selecting the average molecular weight to be 50, 70, 90, or 100 kDa by specifically disclosing these particular values as alternative embodiments for their invention. For example, see MPEP 2131.03 at I. providing that ‘“If the prior art discloses a point within the claimed range, the prior art anticipates the claim.” UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023).’ Further, Alevizopoulos teaches the sulfated polysaccharides are generally from about 4 kDa to about 5 MDa such as 50, 70, 90, 100, 300 kDa, or in between these values, and teaches it was known to separate fractions of different sizes or different molecular weight cutoffs. Therefore Alevizopoulis in itself provides guidance for selecting the average molecular weight from within the disclosed range and with additional of guidance of their specifically disclosed values as bounding values.
Regarding Applicant’s remarks that Alevizopoulis teach selecting the average molecular weight of the sulfated polysaccharides as a results-effective parameter, MPEP 2144.05 at II.B. provides “However, in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), the Supreme Court held that “obvious to try” was a valid rationale for an obviousness finding, for example, when there is a “design need” or “market demand” and there are a “finite number” of solutions. 550 U.S. at 421, 82 USPQ2d at 1397 … Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.” In this case, Alevizopoulis in itself provides guidance for selecting the average molecular weight from within the disclosed range and with additional of guidance of their specifically disclosed values as bounding values. Selection of the average molecular weight of the sulfated polysaccharides based on a known result-effective variable, or particularly as a result-effective variable in order to affect biological efficacy as suggested by Applicant, is not required to be the only motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. In this case Alevizopoulis does not describe the reason for this selection of the average molecular weight of the sulfated polysaccharides, but within itself provides guidance and therefore motivation for selecting the average molecular weight of the sulfated polysaccharides.
Amended Claims 15-18 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Alevizopoulos (WO 2015/082356 A1, published 11 June 2015, provided by Applicant in IDS filed 21 Dec 2022) as applied to claim1-17 and 19-22 above, and further in view of Pujol et al. (Topics in Heterocyclic Chemistry, Springer-Verlag Berlin Heidelberg, 2007, volume 11, p259-281, cited in PTO-892).
Alevizopoulos discloses and teaches as above as applied to amended claims 1-2, 5-14, and 19-22. Alevizopoulos further teaches the composition can optionally include an antimicrobial agent such as an antiviral agent (page 20, line 10-25).
Alevizopoulos does not specifically disclose the fucoidan has a sulfate content of 20% to 40% (w/w) (claim 18 and 25). Alevizopoulos does not specifically disclose the fucoidan has an average molecular weight of 150 kDa and a lower molecular weight cut-off of 10 kDa. (claim 25)
Pujol et al. teaches the inhibitory action of polyanionic substances on virus replication was reported more than 50 years ago. Seaweeds, marine invertebrates, and higher plants represent abundant sources of novel compounds of proved antiviral activity. Natural sulfated polysaccharides (SPs) are potent in vitro inhibitors of a wide variety of enveloped viruses including respiratory syncytial virus (RSV) (page 259, paragraph 1). The broad class of sulfated polysaccharides (SPs) include sulfated homopolysaccharides, sulfated heteropolysaccharides, sulfoglycolipids, carrageenans, and fucoidans. SPs are believed to be of potential therapeutic importance because they can mimic sugar-rich molecules known as glycosaminoglycans (GAGs) present in cell membranes. Heparan sulfate (HS) receptors on cell surfaces are important in many physiological and pathological processes and are essential points for viral entry in susceptible cells. It has been postulated that SPs may compete for binding sites normally occupied by GAGs and thus inhibit these processes (paragraph spanning pages 260-261). Brown seaweeds are known to produce different polysaccharides, namely alginates, laminarans, and fucoidans. Fucoidans always contain essentially L-fucose and sulfate, together with minor amounts of D-xylose, D-galactose, D-mannose, and D-glucuronic acid (page 266, paragraph 1). The structural requirements for antiviral activity include the molecular weight and the anion groups. It is known that the antiviral activity of SPs increases with the molecular weight, tending to level off after ∼100 kDa, and that the highest activity is in the range of 10–100 kDa. Sulfated seaweed polysaccharides with degrees of sulfation lower than 20–22% usually do not show activity (page 276, section 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Alevizopoulos in view of Pujol et al. in order to select the sulfate content of the sulfated polysaccharides of Alevizopoulos. One of ordinary skill in the art would have been motivated to combine Alevizopoulos in view of Pujol et al. with a reasonable expectation of success because both Alevizopoulos and Pujol et al. are drawn to sulfated polysaccharides including fucoidan having activity against respiratory tract and/or respiratory mucosal-related conditions such as viral conditions, Alevizopoulos teaches the composition can optionally include an antiviral agent, suggesting antiviral activity is desired, and Pujol et al. teaches both molecular weight and degrees of sulfation are known structural requirements for antiviral activity of sulfated polysaccharides, suggesting it would have obvious to one of ordinary skill in the art to select the sulfate content of the fucoidan taught by Alevizopoulos to have a degree of sulfation of 20–22% in order to provide the advantage of antiviral activity taught by Pujol et al.
Regarding claims 17 and 25 reciting the molecular weight of the fucoidan, Pujol et al. it is known that the antiviral activity of SPs increases with the molecular weight, tending to level off after ∼100 kDa, and Alevizopoulos teaches selection of the average molecular weight as detailed above. Further, MPEP 2123 II. provides “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).” In this case, Pujol et al. teaching that antiviral activity of SPs tend to level off after ∼100 kDa does not teach away from the broader disclosure of Alevizopoulos because “level off” suggests that selecting a molecular weight greater than the optimal range of 10–100 kDa would not reduce the desired antiviral activity.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 20 March 2026, have been fully considered and not found to be fully persuasive.
Applicant’s remarks regarding Alevizopoulis and the intended use of the claimed “Pharmaceutical composition” are addressed above.
Applicant’s remarks regarding the recognition that molecular weight and degree of sulfation are result-effective variables are additionally addressed by the new grounds of rejection over Alevizopoulos in view of Pujol et al.
See also MPEP 2144 at VI. providing that “The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006)” In this case Pujol et al. teaches natural SPs are effective in inhibiting a wide range of enveloped viruses, whereas nonenveloped viruses are not significantly susceptible to these compounds (page 267, paragraph 5). MPEP 716.02(a) provides, for example at III., “Presence of a property not possessed by the prior art is evidence of nonobviousness. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)” However, MPEP 716.02(d) provides “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.”” In this case, if the claimed composition is asserted to possess a property not possessed by the prior art, such as activity against a nonenveloped rhinovirus, it is not clear that the evidence is commensurate in scope with the claims, where claim 1 encompasses all fucoidans, whereas claim 25 specifies the fucoidan is extracted from Undaria pinnatifida, the sulfate content of 20% to 40% (w/w), and an average molecular weight of 150 kDa and a lower molecular weight cut-off of 10 kDa. However, Pujol et al. teaches “In spite of the many studies attempting to determine the fine structure of the fucoidans, only a few examples of regularity were found. The differences in the structural details are not due to the heterogeneity of the samples but to extreme compositional and structural dispersion, much larger than that normally found in plant polysaccharides.” (page 266, paragraph 1) Therefore, if the claimed composition is asserted to possess a property not possessed by the prior art, such as activity against a nonenveloped rhinovirus, it is not clear that evidence provided is commensurate in scope with the claimed invention.
Conclusion
No claim is found to be allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
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, Scarlett Goon can be reached at (571)270-5241. 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.
/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
Prosecution Insights