DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examiner under the first inventor to file provisions of the AIA .
Priority
The instant application is a 371 of PCT/US2021/058321 filed on 11/05/2021, which claims
domestic benefit to US provisional application no. 63/110,736 filed on 11/06/2020.
It is noted that benefits to a US provisional application must have sufficient written description and enablement for the claimed invention as stated in MPEP 2136.03 III.
Here, the claims are drawn to a method of treating SARS-CoV-2 infection by administering an effective amount of Prolectin-I.
However, the US provisional application no. 63/110,736 only discloses the use of a Prolectin-M for treating SARS-CoV-2 and does not disclose or suggest a Prolectin-l.
It is noted that the PCT/US2021/058321 application does provide sufficient support for the use of Prolectin-l for treating SARS-CoV-2.
Therefore, the effective filing date of the claimed invention is to the PCT/US2021/058321 application filed on 11/05/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/20/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Claims
The claim amendments and remarks filed on 04/20/2026 is acknowledged. Claims 1, 5-6, and 18 are amended. Claims 7-8 and 11 are cancelled.
Accordingly, claims 1-6, 9-10, and 12-23 are pending and being examined on the merits herein.
Withdrawn Objections/Rejections
The objection to the specification is withdrawn because the amended specification now properly recites the regression equation on page 12 lines 32.
The 35 USC 112(a) rejection over claims 3, 5-6, 9-10, and 12 are withdrawn because claim 5 was previously rejected for reciting increasing the copy number of a SARS-CoV-2 gene, whereas the specification only provides support for increasing the cycle threshold (ct) number of a SARS-CoV-2 gene. Furthermore, these claims were also rejected for only providing support for one species of a pectin polysaccharide (ProLectin-l) for performing the recited functions and not providing enough support for the previous scope of pectin polysaccharides in performing the recited functions.
However, Applicant has now amended claim 5 to recite “increases the cycle threshold (ct) number of SARS-CoV-2 gene”, and claim 1 now recites that the pectin polysaccharides are Prolectin-l. Therefore, the claims now have sufficient written description support.
The 35 USC 102 rejection over Eliaz is withdrawn because this rejection was previously applied on meeting the limitation of “pectin polysaccharides”. However, Applicant has amended the claims such that the “pectin polysaccharides” are “Prolectin-l”, which has changed the scope of the claims and requires new search and consideration.
The 35 USC 103 rejection over Eliaz in view of Muntendam is withdrawn because this rejection was previously applied on meeting the limitation of “pectin polysaccharides”. However, Applicant has amended the claims such that the “pectin polysaccharides” are “Prolectin-l”, which has changed the scope of the claims and requires new search and consideration
The provisional non-statutory double patenting rejections over 18/847,466 are withdrawn because this rejection was previously applied on meeting the limitation of “pectin polysaccharides”. However, Applicant has amended the claims such that the “pectin polysaccharides” are “Prolectin-l”, which has changed the scope of the claims and requires new search and consideration
Claim Rejections - 35 USC § 112(b)
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 1-6, 9-10, and 12-23 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.
Claims 1 and 18 contain the trademark/trade name “Prolectin” as evidenced by TM search (in PTO-892).
Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name.
In the present case, the trademark/trade name “Prolectin” is used to identify/describe the “Prolectin-l” compound and, accordingly, the identification/description is indefinite.
Claims 2-6, 9-10, 12-17, and 19-21 depend from either claim 1 or claim 18, but do no overcome the described indefinite issue.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 9-10, and 12-23 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.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Formal, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) The breadth of the claims,
2) The nature of the invention,
3) The state of the prior art,
4) The level of one of ordinary skill,
5) The level of predictability in the art,
6) The amount of direction provided by the inventor,
7) The existence of working examples, and
8) The quantity of experimentation necessary
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention, the breadth of the claims, and relative skill level
The nature of the invention and breadth of the claims relates to a method of treating a SARS-CoV-2 infection in a subject, the method comprising administering to the subject an effective amount of pectin polysaccharides, wherein the pectin polysaccharides are Prolectin-l.
The relative skill of those in the art is high, that of an MD or PHD, someone with experience in the recited disease and administered compound.
The amount of direction or guidance provided and the presence or absence of working examples
Applicant demonstrates in Example 1 (pages 12-14) the inhibition of a patient sample derived strain of SARS-CoV-2 virus by administering the Prolectin-l at a dosage as disclosed in Table 1 (page 13).
While Applicant has demonstrated sufficient support to use the claimed invention, Applicant has not provided enough guidance on how to make the claimed invention (Prolectin-l).
Here, Applicant only provides in Example 2 (pages 14-16) a NMR analysis of Prolectin-l and identified the percentages of specific residues and glycosidic linkage present in the Prolectin-l as seen in Table 5 (page 15). Applicant also discloses that the Prolectin-l contained weak signals of amino acids (lines 3-4 page 16). Furthermore, Applicant has only provided a general disclosure on how to make pectin polysaccharides in page 7 lines 9-17), in which Applicant states the pectin polysaccharides may be obtained via processing of a variety of crude fruit pectins and can be obtained by chemical, enzymatic, physical treatment, and purification.
Furthermore, Applicant has not disclosed or suggested the specific starting materials and processing conditions/parameters required in order to make the recited Prolectin-l compound. Therefore, an ordinary skilled artisan would not be able to predictably determine what components and/or processing steps to use and whether or not the selected components and/or steps forms the recited Prolectin-l compound.
The state and predictability of the art
The state of the prior art such as in Maxwell (in PTO-892 dated 10/20/2025) discloses that pectins are complex structural polysaccharides contained in the cell walls of terrestrial plants, and that there are interests within this field for “modified pectins”, which are broken down small fragments of the pectin polysaccharides (see left and right columns page 64). Furthermore, Maxwell discloses that modified pectins are rich in galactans (page 64 right column second paragraph), and that there are several methods for making these modified pectins using assorted extraction methods, sources of plants, and varying fragmentation techniques (page 64 right column second paragraph).
However, the prior art does not disclose the Prolectin-l compound and/or its structure. Therefore, there is no predictability in the art in regards to the Prolectin-l compound.
The quantity of experimentation necessary
Because of the unpredictability of the art, and in the absence of a disclosed method to make the claimed Prolectin-l, one of ordinary skilled in the art would not be able to predictably make the claimed invention. Furthermore, the quantity of experimentation required to make the Prolectin-l is undue because the NMR data provided by Applicant only identifies what monomers and/or linkages are present in the compound but does not provide the full structural detail of this compound, and Applicant has only provided a general disclosure for making pectins. Furthermore, the Prolectin-l compound is not recognized in the prior art. Lastly, the instant specification discloses that the Prolectin-l compound contains amino acids based on the NMR data, and Applicant has not disclosed what these amino acids are and/or its structures as well as whether these additional amino acids structures on the Prolectin-l contribute to the claimed activity. Therefore, an ordinary skilled artisan would not be able to determine without undue experimentation if the recited Prolectin-l is made.
Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Conclusion
No claim is found 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.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693
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