@20248Notice 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
Application status
In response to the previous Office action, a non-Final rejection (mailed on 12/22/2025), Applicants filed a response and amendment received on 03/19/2026. Said amendment canceled Claims 1-32 and 34-37, and amended Claims 49. Thus, Claims 33 and 38-51 are at issue and present for examination.
Claim Objections - MAINTAINED
Claim 49 is objected to because of the following informalities:
The previous objection to Claim 49 is maintained because the recitation of “---SEQ ID NO: 02---” which can be substantially improved with respect to form. The Examiner suggests replacing the noted phrase with “SEQ ID NO: 2” (the Examiner notes that “---” symbol is used to annotate the Examiner’s suggestion, and as such, this “---” symbol should not be included in the claims.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 102 - MAINTAINED
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The previous rejection of Claims 33, 38-39 and 47-51 under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Whitsett et al. (US Patent No. 10632178) is maintained.
The instant claims are drawn to a pharmaceutical composition for use in treating or ameliorating a viral infection comprising a coronavirus in a subject, wherein the pharmaceutical composition comprises a recombinant human surfactant protein D (rhSP-D), wherein the viral infection comprises SARS-CoV-2, and wherein the SARS-CoV-2 comprises an S1 protein of (1) a Wuhan wildtype or (2) a Wuhan variant comprising an N501Y mutation or a D614G mutation.
Whitsett et al. teach a pharmaceutical composition comprising recombinant human surfactant protein D as set forth in SEQ ID NO: 2, which is 100% identical to Applicants’ SEQ ID NO: 2 (see sequence search result available in SCV under 20251216_202852_us-17-920-245-2.rai, which has been copied/pasted below for Applicants’ convenience), wherein the dose of rhSP-D is [1] about 0.1 mg/kg to about 10 mg/kg body weight, or [2] 1.4 mg/ml (7 mg / 5 ml of buffer) in a buffer, for treatment of a subject, which is human (mammal) (see claims 1, 9 and 14; column 3, lines 64-65; column 9, lines 53-55), thereby anticipating claims 33, 38-39 and 48-51.
It is noted by the Examiner the “intended use” limitations recited in claims 33, 38-39 and 51 are included in this rejection, i.e.,
[a] “for use in treating or ameliorating a viral infection comprising a coronavirus in a subject” as recited in the preamble of claim 33, or
[b] what the viral infection comprises as recited in claims 38-39 and 51,
because they do not result in a structural difference between the claimed composition and the prior art in order to distinguish the claimed composition from that of the prior art. Therefore, because Applicants’ claimed composition is identical in structure to the pharmaceutical composition as taught by Whitsett et al., it anticipates claimed invention regardless of the “intended use” limitations.
For the reasons provided herein, the invention as claimed is anticipated by teachings of Whitsett et al.
US-16-190-456-2
Filing date in PALM: 2018-11-14
Sequence 2, US/16190456
Patent No. 10632178
GENERAL INFORMATION
APPLICANT: Jeffrey A. Whitsett
APPLICANT: Machiko Ikegami
TITLE OF INVENTION: SURFACTANT PROTEIN D FOR THE TREATMENT
TITLE OF INVENTION: OF DISORDERS ASSOCIATED WITH LUNG INJURY
FILE REFERENCE: AIRWY.003D1
CURRENT APPLICATION NUMBER: US/16/190,456
CURRENT FILING DATE: 2018-11-14
PRIOR APPLICATION NUMBER: 15/341383
PRIOR FILING DATE: 2016-11-02
PRIOR APPLICATION NUMBER: 14/062682
PRIOR FILING DATE: 2013-10-24
PRIOR APPLICATION NUMBER: 13/366144
PRIOR FILING DATE: 2012-02-03
PRIOR APPLICATION NUMBER: 61/439760
PRIOR FILING DATE: 2011-02-04
NUMBER OF SEQ ID NOS: 18
SEQ ID NO 2
LENGTH: 355
TYPE: PRT
ORGANISM: Homo sapien
ALIGNMENT:
Query Match 100.0%; Score 1906; Length 355;
Best Local Similarity 100.0%;
Matches 355; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AEMKTYSHRTMPSACTLVMCSSVESGLPGRDGRDGREGPRGEKGDPGLPGAAGQAGMPGQ 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AEMKTYSHRTMPSACTLVMCSSVESGLPGRDGRDGREGPRGEKGDPGLPGAAGQAGMPGQ 60
Qy 61 AGPVGPKGDNGSVGEPGPKGDTGPSGPPGPPGVPGPAGREGPLGKQGNIGPQGKPGPKGE 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AGPVGPKGDNGSVGEPGPKGDTGPSGPPGPPGVPGPAGREGPLGKQGNIGPQGKPGPKGE 120
Qy 121 AGPKGEVGAPGMQGSAGARGLAGPKGERGVPGERGVPGNTGAAGSAGAMGPQGSPGARGP 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 AGPKGEVGAPGMQGSAGARGLAGPKGERGVPGERGVPGNTGAAGSAGAMGPQGSPGARGP 180
Qy 181 PGLKGDKGIPGDKGAKGESGLPDVASLRQQVEALQGQVQHLQAAFSQYKKVELFPNGQSV 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 PGLKGDKGIPGDKGAKGESGLPDVASLRQQVEALQGQVQHLQAAFSQYKKVELFPNGQSV 240
Qy 241 GEKIFKTAGFVKPFTEAQLLCTQAGGQLASPRSAAENAALQQLVVAKNEAAFLSMTDSKT 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 GEKIFKTAGFVKPFTEAQLLCTQAGGQLASPRSAAENAALQQLVVAKNEAAFLSMTDSKT 300
Qy 301 EGKFTYPTGESLVYSNWAPGEPNDDGGSEDCVEIFTNGKWNDRACGEKRLVVCEF 355
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 EGKFTYPTGESLVYSNWAPGEPNDDGGSEDCVEIFTNGKWNDRACGEKRLVVCEF 355
Applicants’ Arguments:
Applicants argue that Whitsett contains no disclosure of treating coronavirus infections, including SARS-CoV-2, nor any teaching regarding therapeutic efficacy or administration for coronavirus etiologies. The Office Action relies solely on sequence identity, noting 100% local similarity across 355 residues between Whitsett's SEQ ID NO: 2 and Applicant's SEQ ID NO: 2. (OA at 4-5.) However, structural identity alone does not establish anticipation of distinct therapeutic applications for different diseases and targets, particularly where the prior art is silent on those applications. See Amgen Inc. v. Sanofi, 598 U.S. 594, 613 (2023); Kelonia Therapeutics, Inc. v. Interius Biotherapeutics, Inc., PGR2024-00008, 2024 WL 2241343, at *14-15 (Patent Tr. & App. Bd. May 17, 2024).
Although the claimed rhSP-D shares sequence identity with Whitsett's SP-D, the claimed composition is defined by its functional efficacy against specific viral proteins unknown at Whitsett's priority date. Claim 33 recites not merely a protein, but a pharmaceutical composition specifically targeting SARS-CoV-2 with an S1 protein of Wuhan wildtype or specific variants (N501Y or D614G mutations). These limitations are not mere intended use statements --- they define the operative context and functional capability of the claimed composition, namely its suitability and efficacy for treating coronavirus infections, including SARS-CoV-2 with specified S1 variants. Whitsett contains no disclosure of SP-D compositions for treating coronavirus infections or addressing SARS-CoV-2 spike S1 protein binding or neutralization, and the Office Action identifies none.
The present application demonstrates that rhSP-D binding efficacy is highly mutation- specific. Binding is significantly decreased against the South African variant (K417N and E484K mutations) compared to the Wuhan wildtype. (See Figs. 4; [0116].) This variant-specific binding demonstrates unique functional characteristics not inherent in Whitsett's general lung injury treatment compositions.
The Office Action identifies no Whitsett disclosure that rhSP-D is formulated, selected, or demonstrated to treat coronavirus or SARS-CoV-2 variant infections, nor does it establish inherency of such treatment properties. Whitsett contains no teachings regarding coronavirus pathogenesis, coronavirus binding targets (e.g., spike Si glycans), or coronavirus treatment protocols. While the Office Action cites Whitsett's claims 1, 9, and 14 and column 3, lines 64-65 and column 9, lines 53-55 for SP-D composition, dose, and buffer (20 mM Tris, 200 mM NaCl, 1 mM EDTA, pH 7.4), it provides no citation to any coronavirus or SARS-CoV-2 Si variant disclosure. (See OA at 5.) Without such disclosure, Whitsett cannot anticipate the claimed coronavirus/SARS-CoV-2 treatment uses and variant-specific limitations.
The Office Action cites Whitsett for teaching a dose of rhSP-D of "about 0.1 mg/kg to about 10 mg/kg body weight." (OA at 4.) Claim 48, however, recites a "concentration of the rhSP-D is from 0.1 mg/ml to 10 mg/ml," which specifies the concentration of the composition itself, not a dosage per body weight. Whitsett's dosage per body weight does not inherently disclose a specific concentration in a pharmaceutical carrier because the volume of carrier used to deliver the dose is not specified.
Claim 47 requires a pH from 5.0 to 7.0. The Office Action notes Whitsett's composition has a pH of 7.4. (OA at 5.) Because pH 7.4 falls outside the claimed range of 5.0 to 7.0, Whitsett does not anticipate claim 47. The compositions are structurally distinct. (See OA at 4; see also OA at 6 ("Whitsett et al. do[es] not teach a buffer comprising histidine, lactose and calcium chloride.").)
The Office Action also has not established inherency. To anticipate under an inherency theory, Whitsett's SP-D compositions must necessarily and inevitably treat coronavirus infections, including SARS-CoV-2 infections characterized by Wuhan wildtype, N501Y, or D614G Si protein variants. See In re Rijckaert, 9 F.3d 1531, 1533 (Fed. Cir. 1993); In re Oelrich, 666 F.2d 578, 581 (Cust. & Pat. App. 1981). The Office Action does not make this showing. The mere possibility that an SP-D composition could be used against a broad set of pathogens is insufficient to meet the strict standard for inherency; the properties must be necessarily present in the prior art disclosure.
Structural identity of the protein and generic formulation/dose do not disclose the
additional claimed requirements directed to the treatment of coronavirus infections, specifically SARS-CoV-2 with defined spike variants. Because Whitsett lacks these functional elements, it cannot anticipate the claims that require them. Accordingly, Applicant submits that Whitsett neither expressly nor inherently discloses the claimed compositions "for use in treating or ameliorating a viral infection comprising a coronavirus" or, as further limited, "wherein the viral infection comprises SARS-CoV-2" with S1 protein of Wuhan wildtype or variants comprising N501Y or D614G. Applicant thus respectfully request withdrawal of the § 102 rejection of claims 33, 38-39, and 47-51 over Whitsett.
Examiner’s Explanation:
Applicants’ arguments have been fully considered but are not deemed persuasive for the following reasons.
It is noted by the Examiner the “intended use” limitations recited in claims 33, 38-39 and 51 are included in this rejection, i.e.,
[a] “for use in treating or ameliorating a viral infection comprising a coronavirus in a subject” as recited in the preamble of claim 33, or
[b] what the viral infection comprises as recited in claims 38-39 and 51,
because they do not result in a structural difference between the claimed composition and the prior art in order to distinguish the claimed composition from that of the prior art. Therefore, because Applicants’ claimed composition is identical in structure to the pharmaceutical composition as taught by Whitsett et al., it anticipates claimed invention regardless of the “intended use” limitations.
In addition, given that these are product claims, the intended use of said claims are not taken into consideration. “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not impart novelty to the claimed product. MPEP 2112.
Furthermore, the rhSP-D taught by Whitsett et al. is identical to Applicants’ claimed composition, and therefore, the rhSP-D would inherently have the identical functional characteristics, i.e., neutralizing SARS-CoV-2 or its variant comprising N501Y or D614G mutation, as evidenced by the instant specification and the instant claims. According to MPEP 2112.01.II. “ ‘Products of identical chemical composition cannot have mutually exclusive properties.’ In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id”.
Contrary to Applicants’ allegation that the limitation “"concentration of the rhSP-D is from 0.1 mg/ml to 10 mg/ml," and that the pH range of 5.0 - 7.0 is not taught by Whitsett et al., the Examiner previously disclosed that the rhSP-D concentration of 1.4 mg/ml (7 mg / 5 ml of buffer) in a buffer, for treatment of a subject, which is human (mammal), and pH of 7.4 which when applying round off is pH 7.0 thereby meeting those specific limitations of the instant claims (see claims 1, 9 and 14; column 3, lines 64-65; column 9, lines 53-55).
For the reasons provided herein, claims 33, 38-39 and 47-51 are anticipated by the teachings of Whitsett et al.
Claim Rejections - 35 U.S.C. § 103 - MAINTAINED
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 previous rejection of Claim 33 and 38-51 under 35 U.S.C. 103 as being unpatentable over Whitsett et al. (US Patent No. 10632178) in view of Huang (US Patent Application Publication No. 20130216499) is maintained.
The instant claims are drawn to a pharmaceutical composition for use in treating or ameliorating a viral infection comprising a coronavirus in a subject, wherein the pharmaceutical composition comprises a recombinant human surfactant protein D (rhSP-D), wherein the viral infection comprises SARS-CoV-2, and wherein the SARS-CoV-2 comprises an S1 protein of (1) a Wuhan wildtype or (2) a Wuhan variant comprising an N501Y mutation or a D614G mutation.
Teachings of Whitsett et al. are as described above.
Whitsett et al. do not teach a buffer comprising histidine, lactose and calcium chloride, and said pharmaceutical composition in a buffer between pH 5.0 – 7.0.
Huang teaches that a pharmaceutical composition comprises a preserver composition comprising lactose from about 1 g to about 25 g; histidine from about 0.1 mM to about 10 mM; and calcium chloride from about 1 mM to about 500 mM, which directly overlap in ranges recited in the instant claims 40-46 (see claims 1-6 of Huang).
Since the Office does not have the facilities for examining and comparing the amount of lactose present in applicants’ pharmaceutical composition which is expressed in mM units from the unit grams used in the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
It would have been obvious to a person of ordinary skill in the art (POSITA) in the art prior to the effective filing date of the claimed invention to make and use the pharmaceutical composition taught by Whitsett et al. and add the preserver composition as taught by Huang. A POSITA would have been motivated to make and use such composition because adding the preserver composition improves bio-stability in a buffer solution during storage of the pharmaceutical composition (see para [0020]). A POSITA would have had a reasonable expectation of success to make and use such composition because all of the required biochemical reagents and techniques were rampantly used as evidenced by Whitsett et al. and Huang prior to the filing of the instant application. For the reasons provided herein, the invention as claimed is prima facie obvious over the combined teachings of the prior art.
Applicants’ Arguments:
Applicants argue that the Office Action relies on Whitsett as the primary reference, citing its disclosure of pharmaceutical compositions comprising recombinant human SP-D with dosing and buffer details. However, Whitsett fails to disclose any teaching regarding: (i) treating or ameliorating coronavirus infections; (ii) targeting SARS-CoV-2; or (iii) the SARS-CoV-2 S1 protein of the Wuhan wildtype or variants comprising the N501Y or D614G mutations. These omissions are fatal to the rejection.
The Examiner acknowledges intended-use limitations in Claim 33's preamble and Claims 38-39 and 51 regarding the viral infection. However, the Examiner improperly treats Whitsett as satisfying the claims based solely on structural features while failing to address: (i) the coronavirus/SARS-CoV-2 therapeutic context or (ii) the variant-specific Sl protein features. This approach is legally insufficient. Under 35 U.S.C. § 103, even assuming the structural features are disclosed, the combination must provide both (a) motivation to apply the composition to the claimed therapeutic use, and (b) a reasonable expectation of success. The Office Action provides neither.
These omissions are central to patentability. The claims recite compositions "for use in treating or ameliorating a viral infection comprising a coronavirus," with targeting of "SARS- CoV-2" and the S1 protein of specific SARS-CoV-2 lineages (Wuhan wildtype; variants comprising N501Y or D614G). Whitsett teaches none of these coronavirus- and variant-specific therapeutic applications.
The Examiner concedes that Whitsett does not teach a buffer comprising histidine, lactose, and calcium chloride, and therefore relies on Huang to supply these constituents and ranges for Claims 40-46. This reliance on a second reference confirms that Whitsett alone does not disclose all claim limitations. More fundamentally, for Claims 33 and 38-39 and 51, Whitsett's silence on coronavirus/SARS-CoV-2 treatment and variant-specific Sl targeting remains unaddressed-a deficiency Huang's buffer teachings cannot cure.
The Examiner's rationale for combining Whitsett with Huang is merely to "add the preserver composition" to improve bio-stability during storage. (OA at 7.) The Office Action provides no rationale for treating coronavirus infections, targeting SARS-CoV-2, or addressing variant-specific Si protein characteristics (Wuhan wildtype; N501Y; D614G). A storage stability rationale cannot supply motivation to repurpose Whitsett's rhSP-D compositions toward coronavirus infections or to target SARS-CoV-2 and its variant-specific Sl features. This represents a fundamental disconnect between the stated rationale and the claimed invention. The Supreme Court requires "some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness." KSR Intern. Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)(quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). Indeed, "[t]he obviousness inquiry does not merely ask whether a skilled artisan could combine the references, but instead asks whether 'they would have been motivated to do so."' Adidas AG v. Nike, Inc., 963 F.3d 1355, 1359 (Fed. Cir. 2020) (quoting InTouch Techs., Inc. v. VGO Commc'ns, Inc., 751 F.3d 1327, 1352 (Fed. Cir. 2014)). The distinction between "could" and "would" is outcome- determinative. The Office Action fails to provide such reasoning connecting the prior art to the claimed coronavirus-specific therapeutic applications.
The Office Action asserts a reasonable expectation of success based on "rampantly used" biochemical reagents and techniques. However, this does not address whether a person of ordinary skill would have reasonably expected rhSP-D, formulated as in Whitsett and preserved as in Huang, to treat or ameliorate SARS-CoV-2 infections, particularly those defined by the S1 protein of the Wuhan wildtype or variants comprising the N501Y or D614G mutations. The reasonable expectation of success must be tied to the specific claimed invention, not general formulation techniques. See In re O'Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988). General availability of biochemical techniques does not establish a reasonable expectation of success for the claimed variant-specific therapeutic outcomes. The Office Action identifies no teaching in Whitsett or Huang addressing coronavirus pathogenesis, SARS-CoV-2-specific binding/neutralization requirements, or variant S1 mutations' implications for therapeutic efficacy-all necessary to reasonably expect success.
The Office Action treats the coronavirus/SARS-CoV-2 and variant Si limitations as mere "intended use," emphasizing structural identity of Whitsett's composition while not pointing to any Whitsett disclosure of the claimed therapeutic indications or target-specific requirements. However, where intended use limitations materially affect the characteristics of the claimed invention or impose meaningful structural or functional requirements, they are entitled to patentable weight and cannot be disregarded. See Poly-Am., L.P. v. GSE Lining Tech., Inc., 383 F.3d 1303, 1309-10 (Fed. Cir. 2004); Eaton Corp. v. Rockwell Intern. Corp., 323 F.3d 1332 (Fed. Cir. 2003); Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). Here, the specific coronavirus and variant Sl limitations define critical functional requirements that distinguish the claimed invention from Whitsett's general rhSP-D compositions.
The specified use and target-variant limitations delineate the scope of the claimed
invention and significantly differentiate it from Whitsett's disclosures. In the absence of any teaching or suggestion within Whitsett (or its proposed combination with Huang) regarding the application of rhSP-D to coronavirus infections-specifically SARS-CoV-2-and considering the recited variant S1 constraints, the rejection fails to demonstrate that the prior art would have guided a skilled artisan to the claimed invention with a reasonable expectation of success. For these reasons, the cited combination provides neither adequate motivation to pursue the claimed therapeutic applications nor a reasonable expectation of achieving them. Accordingly, the applicant respectfully requests withdrawal of the § 103 rejection for claims 33 and 38-51.
Examiner’s Explanation:
Applicants’ arguments have been fully considered but are not deemed persuasive for the following reasons.
It is noted by the Examiner the “intended use” limitations recited in claims are included in this rejection, i.e.,
[a] “for use in treating or ameliorating a viral infection comprising a coronavirus in a subject” as recited in the preamble of claim 33, or
[b] what the viral infection comprises as recited in claims 38-39 and 51,
because they do not result in a structural difference between the claimed composition and the prior art in order to distinguish the claimed composition from that of the prior art. Therefore, because Applicants’ claimed composition is identical in structure to the pharmaceutical composition as taught by Whitsett et al., it reads on the claimed invention regardless of the “intended use” limitations.
In addition, given that these are product claims, the intended use of said claims are not taken into consideration. “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not impart novelty to the claimed product. MPEP 2112.
Furthermore, the rhSP-D taught by Whitsett et al. is identical to Applicants’ claimed composition, and therefore, the rhSP-D would inherently have the identical functional characteristics, i.e., neutralizing SARS-CoV-2 or its variant comprising N501Y or D614G mutation, as evidenced by the instant specification and the instant claims. According to MPEP 2112.01.II. “ ‘Products of identical chemical composition cannot have mutually exclusive properties.’ In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id”.
Contrary to Applicants’ allegation that the Office Action provides no rationale for treating coronavirus infections limitation, this has already been met by the teachings of Whitsett et al. since the rhSP-D taught by Whitsett et al. is identical to Applicants’ claimed composition, and therefore, the rhSP-D would inherently have the identical functional characteristics, i.e., neutralizing SARS-CoV-2 or its variant comprising N501Y or D614G mutation, as evidenced by the instant specification and the instant claims.
Furthermore, Applicants’ allegation regarding the lack of expectation of success because the Office Action identifies no teaching in Whitsett or Huang addressing coronavirus pathogenesis, SARS-CoV-2-specific binding/neutralization requirements, or variant S1 mutations' implications for therapeutic efficacy-all necessary is moot because all of these are inherent in the functional characteristics of the rhSP-D taught by Whitsett et al. which is 100% identical to Applicants’ claimed composition (italicized for added emphasis).
For the reasons provided herein, claims 33 and 38-51 are prima facie obvious over the combined teachings of the prior art.
Double Patenting - MAINTAINED
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
The previous rejection of Claim 33 and 38-51 on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12491234 is maintained. Although the claims at issue are not identical, they are not patentably distinct from each other because since the claims, if allowed, would improperly extend the "right to exclude" already granted in the patent.
Claims of ‘234 patent are drawn to a pharmaceutical composition comprising: from about 0.1 mg/ml to about 10 mg/ml of a recombinant human surfactant protein D (rhSP-D); from about 3 mM to about 7 mM of a histidine buffer; from 200 mM to 300 mM of a sugar, and from about 0.1 mM to about 10 mM of a calcium salt, which directly overlap in scope with the instant claims 33 and 38-51. Even though instant claims recite the “intended use” limitations in claim 33, and claims 38-39 and 51, i.e.,
[a] “for use in treating or ameliorating a viral infection comprising a coronavirus in a subject” as recited in the preamble of claim 33, or
[b] what the viral infection comprises as recited in claims 38-39 and 51,
because they do not result in a structural difference between the claimed composition and the pharmaceutical composition of ‘234 patent, and the fact that all of the buffer constituents and their concentration ranges claimed in ‘234 patent are identical to those claimed in the instant claims 40-46, the scope of the instant claims and the claims of ‘234 patent directly overlap. As such, the instant claims, if allowed, would improperly extend the "right to exclude" already granted in the ‘234 patent.
Applicants’ Arguments:
New and useful processes are separately patentable from compositions of matter. 35 U.S.C. § 101. The term "process" includes "a new use of a known ... composition of matter." 35 U.S.C. § 100(b); MPEP 2106. Even if the composition disclosed in Rosenbaum is not patentably distinct from the components of the composition recited in the present claims-which applicant does not concede-the present claims are nonobvious over claims 1-15 of Rosenbaum because Rosenbaum neither discloses nor suggests at least a pharmaceutical composition "for use in treating or ameliorating a viral infection comprising a coronavirus in a subject, "wherein the viral infection comprises SARS-CoV-2," and wherein the SARS-CoV-2 comprises an Si protein of (1) a Wuhan wildtype or (2) a Wuhan variant comprising an N501Y mutation or a D614G mutation," as specified in independent claim 33. Rosenbaum teaches none of these coronavirus- and variant-specific therapeutic applications, and for the reasons discussed above for the rejections under 35 U.S.C. §§ 102 and 103, it is improper as a matter of law for the Office Action to ignore them.
Examiner’s Explanation:
Applicants’ arguments have been fully considered but are not deemed persuasive for the following reasons.
It is noted by the Examiner the “intended use” limitations recited in claims are included in this rejection, i.e.,
[a] “for use in treating or ameliorating a viral infection comprising a coronavirus in a subject” as recited in the preamble of claim 33, or
[b] what the viral infection comprises as recited in claims 38-39 and 51,
because they do not result in a structural difference between the claimed composition and the ‘234 patent in order to distinguish the claimed composition from that of the claimed subject matter of the ‘234 patent. Therefore, because Applicants’ claimed composition is identical in structure to that of the ‘234 patent and the scope of these claims directly overlap.
Furthermore, the rhSP-D taught by the ‘234 patent is identical to Applicants’ claimed composition, and therefore, the rhSP-D would inherently have the identical functional characteristics, i.e., neutralizing SARS-CoV-2 or its variant comprising N501Y or D614G mutation, as evidenced by the instant specification and the instant claims. According to MPEP 2112.01.II. “ ‘Products of identical chemical composition cannot have mutually exclusive properties.’ In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the ‘234 patent teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id”.
For the reasons provided previously and herein, the instant rejection is maintained.
Conclusion
Claims 33 and 38-51 are rejected for the reasons as stated above. Applicants must respond to the objections/rejections in this Office action to be fully responsive in prosecution.
THIS ACTION IS MADE FINAL. 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 extension fee 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 JAE W LEE whose telephone number is (571)272-9949. The examiner can normally be reached on M-F between 9:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached on (571)272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAE W LEE/
Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
Prosecution Insights