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 . 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.
Priority
The instant application is a 371 of PCT/IB2020/000616 filed on 07/24/2020, which claims domestic benefit to US provisional application no. 62/879,202 filed on 07/26/2019.
Status of the Claims
The claim amendments and remarks filed on 02/23/2026 are acknowledged. Claims 1-26, 39-42, 46-47, and 49-50 are cancelled.
Claims 27-38, 43-45, 48, and 51 are pending.
Claims 27-37 were previously withdrawn in the office action dated 04/04/2025 from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Accordingly, claims 38, 43-45, 48, and 51 are being examined on the merits herein.
The following grounds of rejection are maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 38, 43-45, 48, and 51 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating psoriasis, does not reasonably provide enablement for providing prophylaxis of psoriasis. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
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 breadth of the claims, the nature of the invention, and relative skill level
The invention relates to a method of treating or providing prophylaxis of psoriasis comprising administering to a subject in need thereof an effective amount of a composition recited in claim 38, 43, and 51. In the absence of an explicit definition in Applicant’s specification, the claims are given their broadest reasonable interpretation. See MPEP 2111. Merriam-Webster (reference included with PTO-892 dated 09/05/2025) defines "prophylaxis" as meaning, "measures designed to preserve health (as of an individual or of society) and prevent the spread of disease." Thus, the broadest reasonable interpretation of “prophylaxis” includes “prevention”, and in the absence of a limiting definition by Applicant, “prevention” is interpreted as defined according to Institute for International Medical Education (IIME, reference included with PTO-892 dated 09/05/2025), which defines “prevention” as promoting health, preserving health, and to restore health when it is impaired, and to minimize suffering and distress (see page 16, “Prevention”. IIME further states that “Primary prevention refers to the protection of health by personal and community wide effects, such as preserving good nutritional status, physical fitness, and emotional well-being, immunizing against infectious diseases, and making the environment safe. Secondary prevention can be defined as the measures available to individuals and populations for the early detection and prompt and effective intervention to correct departures from good health. Tertiary prevention consists of the measures available to reduce or eliminate long-term”
Therefore, in order to give the broadest reasonable interpretation to the claims, “prophylaxis" is thus interpreted to mean the complete blocking or protection of all symptoms or effects of a disorder or condition for an indefinite period of time in all population types (gender, age, etc.).
The claim is broad insofar as it recites providing prophylaxis of psoriasis. As described above, providing prophylaxis indicates that any type of psoriasis must never occur by administering the claimed agents.
The relative skill of those in the art is high, that of an MD or PHD, someone with experience in psoriasis.
The amount of direction or guidance provided and the presence or absence of working examples
Applicant demonstrates in Examples 1-5 (page 20 in instant specification) that several human patients were administered NGNA orally and observed a reduction of symptoms associated with psoriasis compared to previous treatments.
The described examples show that the claimed composition was effective in reducing the symptoms associated with psoriasis but does not show that psoriasis was prevented. Furthermore, the disclosure and examples do not teach or suggest a method to predictably identify patients who would get psoriasis and then to further determine if the psoriasis can be prevented by administering the claimed compositions.
The state and predictability of the art
The state of the prior art discloses that it is unclear and complex in how a person develops psoriasis. For example, Zangeneh et al. (in PTO-892 dated 09/05/2025) discloses that although the skin disease psoriasis was first recognized as a distinct disease as early as 1808, its pathogenic mechanisms have eluded investigators for decades (see first paragraph on page 3). Zangeneh et al. discloses several different types of psoriasis with varying symptoms and conditions (see pages 4-14). Zangeneh et al. discloses several different findings and potential mechanisms for the pathophysiology of psoriasis (pages 14-22), which suggests unpredictably in the development of psoriasis. Zangeneh et al. concludes that there is no universal standard of care for patients with moderate to severe psoriasis, and the benefits and risks of systemic therapy must be weighed carefully for each patient to ensure optimal management of psoriasis symptoms and minimization of acute and cumulative toxicities (see last paragraph on page 26).
Therefore, due to the complexities involved for humans developing psoriasis combined with no known standard treatment of psoriasis and thus incomplete information to develop effective methods to prevent psoriasis, the prophylaxis application for psoriasis using the claimed composition is highly unpredictable in the arts.
The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of a predictable method to identify patients who would develop these diseases without treatment, no one skilled in the art would accept the assertion that the instantly claimed agents could be predictably used to provide prophylaxis of psoriasis as inferred by the claim and contemplated by the specification. Furthermore, the quantity of experimentation to develop a method that could be used to provide prophylaxis of psoriasis would be undue because a method to predictably identify a patient who would get psoriasis does not exist and as described above, one of ordinary skill would have to develop this method such that the claimed method could then be used as to provide prophylaxis of psoriasis. 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.
Response to Arguments
Applicant’s arguments filed on 02/23/2026 have been fully considered but were not persuasive.
Applicant states in regards to the 35 USC 112(a) scope of enablement rejection that the interpretation of the term “prophylaxis” as “the complete blocking or protection of all symptoms or effects of a disorder or condition for an indefinite period of time in all population types” cannot be derived from the cited references and contradicts the established medical meaning of “prophylaxis” and therefore is not the broadest reasonable interpretation of the term in light of the specification. Applicant states that the cited references (Merriam-Webster and Wojtczak glossary) do not support the described interpretation above and only contemplate reducing or limiting a disease and not necessarily eliminating it entirely.
Applicant states the correct broadest reasonable interpretation of “prophylaxis”, read in light of the specification, is “administration of a therapeutic agent to a subject at risk of developing a disease in order to reduce that risk”. Applicant states that the specification provides this operative definition explicitly in which “an effective amount of sialic acid or sialic acid-containing compounds is administered orally or topically to a subject at risk of developing psoriasis to provide prophylaxis”. Applicant states this is the standard clinical meaning of prophylaxis, and should govern the enablement inquiry.
Applicant’s arguments described above were not found persuasive because it is noted that Applicant has not provided an explicit definition of the term “prophylaxis” in the specification. Therefore, while Applicant may be enabled for the term “prophylaxis” under the interpretation that it is meant to reduce the risk of developing a disease, the term “prophylaxis”, absent this explicit definition in the specification, still encompasses a preventive measure as supported by the Merriam-Webster and Wojtczak glossary references. Here, the Merriam-Webster reference defines "prophylaxis" as meaning, "measures designed to preserve health (as of an individual or of society) and prevent the spread of disease.", which means the term “prophylaxis” is not only limited to measures of reducing or limiting a disease as stated by Applicant but can also include measures for preventing the disease. Thus, the broadest reasonable interpretation of “prophylaxis” includes “prevention”, and as discussed in the Wojtczak glossary reference, the term prevention includes the protection of health.
Applicant further states in regards to the 35 USC 112(a) scope of enablement rejection that under the interpretation that “prophylaxis” is “administration of a therapeutic agent to a subject at risk of developing a disease in order to reduce that risk”, the specification fully enables this practice without undue experimentation. Here, Applicant points to the examples in their specification in which the NGNA compound was administered by different routes of administration to a patient with psoriasis and subsequently reduced the symptoms associated with psoriasis as compared to previous treatments. Applicant states that an ordinary skilled artisan would readily recognize based on the specification to administer NGNA for at-risk subjects and therefore could administer NGNA prophylactically against psoriasis for an at-risk patient.
Applicant states that the discussion regarding the unpredictability of developing psoriasis is misapplied for the Wands unpredictability factor because this factor only inquires whether an ordinary skilled artisan could make and use the claimed invention without undue experimentation and not whether the underlying disease mechanism is fully understood. Applicant states the unpredictability in psoriasis etiology has no bearing on whether or not the act of administering NGNA to an at-risk subject can be performed without undue experimentation. Applicant further states that the Zangeneh reference concludes that effective treatment options exist for psoriasis and does not disclose that it is unresponsive to prophylactic measures.
Applicant also states that “a method to predictably identify a patient who would get psoriasis does not exist” imposes a requirement that the claimed method include a novel patient-selection methodology, which is not a limitation of the pending claims. Therefore, Applicant states that the Examiner has not identified any experimentation that an ordinary skilled artisan would need to perform to practice the prophylactic embodiment beyond what is already within skill to the ordinary skilled artisan.
Applicant’s arguments described above were not found persuasive because, as described above, absent an explicit definition to the specification, the term “prophylaxis” can be interpreted as a preventive measure and not necessarily as a means to reduce the risk of a disease. Therefore, while the specification may be enabled to practice prophylaxis under the interpretation of reducing the risk of a patient developing psoriasis, the specification is not enabled for practicing prophylaxis under the interpretation of preventing psoriasis in a patient because there are no working examples or an explanation that an ordinary skilled artisan could identify whether or not the psoriasis was prevented from the administration of the NGNA compound. It is noted that in order to satisfy the enablement require, the specification must describe how to make and how to use the invention without undue experimentation as stated in MPEP 2164.01. Therefore, the identification of how psoriasis is developed is necessary to be enabled to use the claimed invention and to practice “prophylaxis” as a preventive measure for developing psoriasis because without this predictable identification, an ordinary skilled artisan would not be able to determine whether or not the “prophylaxis” against psoriasis was achieved with the administered NGNA compound. Furthermore, as described above in the state of the prior art, the underlying mechanisms of developing psoriasis is unpredictable. Therefore, an ordinary skilled artisan would have to engage in undue experimentation because the ordinary skilled artisan would have to first identify how the psoriasis is developed in order to determine if the psoriasis is prevented from administering the claimed NGNA compound.
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.
Claim(s) 38, 43-45, 48, and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Remmereit et al (US 20160024125 in PTO-892 dated 04/04/2025) in view of Anderson et al (WO 2000006115 in IDS filed 10/26/2022).
Remmereit et al. discloses lipid compositions and methods of making and using (see Abstract). Remmereit et al. discloses that the lipids in the composition can comprise of omega-3 fatty acid moieties such as EPA and DHA (see paragraph [0008]). Remmereit et al. discloses their lipid compositions have use in the manufacture of a medicament for the treatment of proliferative skin disorders such as psoriasis (see paragraph [0239]). Remmereit et al. discloses that a common form of psoriasis, known as psoriasis vulgaris (plaque), is characterized by well-demarcated erythematous plaques covered by thick, silvery scales (see paragraph [0288]), and further discloses that there is a need for a new method and a new composition to inhibit keratinocyte proliferation to alleviate the symptoms of skin proliferation diseases such as psoriasis (see paragraph [0293]). Furthermore, Remmereit et al. discloses that their lipid compositions may be combined with one or more sialic acid analogs (see paragraph [0033]). Remmereit et al. discloses several sialic acid analogs such as N-acetyl-neuraminic acid (NANA), N-glycolylneuraminic acid (NGNA), and N-Acetyl-D-mannosamine (see paragraph [0033]). Lastly, Remmereit et al. discloses their lipid compositions can additionally comprise polar complexes such as gangliosides (see paragraph [0091]).
The teachings of Remmereit et al. differ from that of the instantly claimed invention in that Remmereit et al. does not exemplify administering their lipid compositions in combination with a NGNA to treat psoriasis. Additionally, Remmereit et al. does not disclose further administering a specific ganglioside such as ganglioside GM3.
Anderson et al. discloses novel sialyl oligosaccharides and their derivatives useful in regulating inflammatory responses, reducing skin irritation, and treating skin reddening, and compositions containing the sialyl oligosaccharides and their derivatives, and methods for their use (see page 7, lines 15-25). Anderson et al. discloses that the anti-inflammatory compounds are generally sialic acids or glycosides of sialic acids, and further discloses that the sialyl compounds in their compositions refer to all naturally occurring structures of sialic acid and lists several sialic acid species such as N-acetyl-neuraminic acid (NANA) and N-glycolylneuraminic acid (NGNA) (see page 13, lines 1-37). Anderson et al. also discloses a topical composition useful for treating skin disorders comprising an effective amount of a substantially purified sialic acid glycoside such as ganglioside GM3 (see claims 1 and 12 of Anderson et al.). Lastly, Anderson et al. discloses that their compositions are suitable for therapeutic treatment of psoriasis (see page 11, lines 3-10).
It would have prima facie obvious to combine Remmereit et al with Anderson et al. before the effective filing date of the claimed invention by selecting NGNA and/or ganglioslide GM3 as disclosed in Anderson for the combination composition disclosed in Remmereit et al. and to further use this combination composition to treat plaque psoriasis as disclosed in Remmereit to arrive at the claimed invention. One of ordinary skill in the art would have made these modifications with a reasonable expectation of success because Remmereit et al. discloses that a common form of psoriasis is plaque psoriasis and provides a motivation to develop new methods and compositions in order to alleviate symptoms of skin proliferation diseases such as psoriasis, and Anderson et al. provides additional guidance that sialic acid derivatives such as NGNA and ganglioside GM3 can function as anti-inflammatory compounds for the treatment of psoriasis. Furthermore, the transitional phrase “consisting essentially of” recited for the composition in the instant claims is being interpreted the same as “comprising” because MPEP 2111.03 III states “… absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising."”. Therefore, the combined teachings of Remmereit and Anderson meet all of the limitations of the instant claims.
Response to Arguments
Applicant’s arguments filed on 02/23/2026 have been fully considered but were not persuasive.
Applicant states in regards to the obviousness rejection over Remmereit in view of Anderson that the transitional phrase “consisting essentially of” is not equivalent to “comprising” because the specification clearly identifies the basic and novel characteristics of the claimed compositions. Applicant states that the basic and novel characteristic of the claimed composition is the anti-psoriatic activity of NGNA as the therapeutic active agent. Applicant points to several sections of the specification to show that the claimed invention utilizes sialic acid or sialic acid-containing compounds to treat psoriasis and further points to the working examples in which NGNA was the sole active agent that was effective to reduce psoriasis symptoms. Therefore, Applicant states that the transitional phrase “consisting essentially of” in the claims encompasses the listed active ingredients (NGNA and compounds in claims 43 and 51) plus any ingredients that do not materially affect those characteristics.
Applicant states that Remmereit requires tetradecylthioacetic acid (TTA), which is a non-oxidable fatty acid analogue with its own distinct pharmaceutical activities, and would materially affect the basic and novel characteristic of the claimed NGNA compositions by adding a second pharmaceutical active with its own mechanism of action. Applicant states that while Remmereit discloses sialic acid analogues such as NGNA that can be included with the TTA lipid composition of Remmereit, Applicant states that the Remmereit compositions are directed toward lipid compositions and utilize TTA as the active ingredient against psoriasis and does not teach that the combined NGNA is anti-psoriatic and can be used alone (without TTA) to treat psoriasis. Therefore, Applicant states that, properly construed, the TTA-containing compositions of Remmereit are excluded and do not fall within scope of the pending claims.
Applicant’s argument described above was not found persuasive because even though the “consisting essentially of” transitional phrase excludes out additional components that materially affect the basic and novel characteristic of the claimed NGNA compound for treating psoriasis, MPEP 2111.03 III states that “If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of "consisting essentially of," applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of the claimed invention” and “[I]t is an applicant’s burden to establish that a step practiced in a prior art method is excluded from his claims by ‘consisting essentially of’ language.".
Here, while Applicant has disclosed that the basic and novel characteristic for the claimed composition is for treating psoriasis, Applicant has not provided sufficient evidence that inclusion of prior art components such as the TTA disclosed in Remmereit would affect this basic and novel characteristic. Therefore, barring any evidence to the contrary, the TTA component disclosed in Remmereit is within scope and can be included in the claimed compositions.
Furthermore, the claimed composition “consisting essentially of” can include “EPA and/or DHA” that are provided as a “free fatty acid, ethyl, ester, triglyceride, and/or phospholipid” as claimed in claim 51.
Here, it is noted the TTA in the lipid compositions of Remmereit are part of a structured phospholipid that can contain the TTA fatty acid moiety as well as EPA/DHA fatty-acid moieties on the phospholipid (see claims 78 and 83). Therefore, the lipid composition of Remmereit is still within scope of the instant claims because Applicant has claimed and provided embodiments that their compositions “consisting essentially of” NGNA can include fatty acid-based phospholipids, and Applicant has not provided evidence that fatty acid-based phospholipids would materially affect the basic and novel characteristic of the claimed NGNA. It is also noted that the combined TTA lipid composition with the sialic acid compounds as described above by the combined teachings of Remmereit and Anderson has the same basic and novel characteristic of using NGNA alongside fatty acid-based phospholipids for treating psoriasis.
Applicant states that neither Remmereit nor Anderson teach NGNA as an anti-psoriatic or anti-inflammatory compound. Applicant states that Remmereit provides no working examples of NGNA for use in any context, and further states that Anderson only identifies NGNA as a naturally occurring variant of sialic acid but does not teach the use of NGNA itself as a therapeutic. Applicant states that the Anderson compounds are sialic acid glycosides which are chemically distinct class from free NGNA, and states that while Anderson discloses that their method involves administering sialic acid or a sialic acid glycoside, the inventive concept of Anderson is focused toward sialyl glycosides and not free NGNA with no working examples or data that free NGNA is anti-psoriatic.
Applicant’s argument described above was not found persuasive because MPEP 2143.02 I states that “Conclusive proof of efficacy is not required to show a reasonable expectation of success … "To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.” … "This court has long rejected a requirement of ‘[c]onclusive proof of efficacy’ for obviousness." … reasoning that "the expectation of success need only be reasonable, not absolute".
Here, even though the teachings of Remmereit and Anderson do not explicit demonstrate the use of NGNA as an anti-psoriatic agent, there is reasonable guidance from these teachings to include NGNA for treating psoriasis because Remmereit discloses embodiments of compositions that further include sialic acids such as NGNA for the purposes of treating skin disorders such as psoriasis, and Anderson also suggests the use of sialic acids as an anti-inflammatory compound for the treatment of psoriasis.
Applicant states that the prior art combination (Remmereit in view of Anderson) fails because the Examiner has not articulated the required motivation to combine the references in the manner necessary to arrive at the claimed invention. Applicant states that in order to arrive at the claimed invention, an ordinary skilled artisan would have to exclude out TTA from the Remmereit and further select NGNA along with ganglioside GM3 and EPA / DHA. Applicant states that there is no motivation to exclude the TTA lipids of Remmereit in favor of selecting NGNA alone or why an ordinary skilled artisan would combine NGNA with a ganglioside without any synergy teaching or why they would form a TTA-free NGNA + EPA/DHA composition.
Applicant’s argument described above was not found persuasive because as discussed above, the TTA lipids of Remmereit are within scope of the instant claims and are not necessarily excluded out from the transitional phrase “consisting essentially of”. Therefore, a motivation to exclude out TTA of Remmereit is not required to arrive at the claimed invention.
Furthermore, it is noted that an explicit teaching of a motivation is not required to combine in the prior art. See MPEP 2143. Here, Remmereit provides guidance that their lipid compositions for treating skin disorders such as psoriasis can further include sialic acids such as N-glycolylneuraminic acid (NGNA) (see paragraph [0033]) as well as polar complexes such as gangliosides (see paragraph [0091]) and omega-3 fatty acid moieties such as EPA and DHA (see paragraph [0008]). Furthermore, Anderson provides guidance of also treating skin disorders such as psoriasis using sialic acids such as NGNA as well as sialic acid glycosides such as ganglioside GM3 (page 13, lines 1-37 and claims 1 and 12). Therefore, an ordinary skilled artisan would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so.
Double Patenting
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.
Claims 38, 43-45, 48, and 51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of U.S. Patent No. 10,259,833 (‘833) in view of Remmereit et al (US 20160024125 in PTO-892 dated 04/04/2025) and Anderson et al (WO 2000006115 in IDS filed 10/26/2022).
Claim 1 of ‘833 recites a method for producing lipids comprising tetradecylthioacetic acid (TTA) and omega-3 fatty acids, the method comprising: 1) providing TTA to algae in vitro; and 2) isolating lipids comprising TTA and omega-3 fatty acid moieties from the algae, wherein said lipids are phospholipids or triglycerides to which the TTA and omega-3 fatty acid moieties are esterified. Claim 8 of ‘833 recites wherein said omega-3 fatty acid moiety is selected from the group consisting of EPA and DHA.
The claims of ‘833 et al. differ from that of the instantly claimed invention in that the claims of ‘833 al. do not recite a NGNA and/or ganglioside GM3.
The independent teachings of Remmereit and Anderson are as described above.
It would have prima facie obvious to combine the claims of ‘833 with Remmereit et al. and Anderson et al. before the effective filing date of the claimed invention by co-administering the produced lipids recited in the claims of ‘833 with a sialic acid such NGNA and/or ganglioside GM3 to treat plaque psoriasis as disclosed in Remmereit and Anderson to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to make these modifications because Remmereit et al. discloses a similar method for producing the same lipids as recited in the claims of ‘833 and provides further guidance to co-administer the lipids with a sialic acid derivative. Furthermore, Anderson et al. provides additional guidance that sialic acids can function as anti-inflammatory compounds and to select a ganglioside GM3 for the treatment of psoriasis.
Response to Arguments
Applicant’s arguments filed on 02/23/2026 have been fully considered but were not persuasive.
Applicant states that the NSDP rejection over ‘883 fails for the same reasons as the obviousness rejection over the combination of Remmereit and Anderson.
Applicant’s argument described above was not found persuasive because the arguments against the obviousness rejection over the combination of Remmereit and Anderson were also not found persuasive as discussed above. Therefore, for the same reasons described above, the NSDP rejection over ‘883 is also maintained.
Conclusion
No claim is found allowable.
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 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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