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 .
DETAILED ACTION
This office action is response to communication filed on 12/01/2025.
Response to Amendment
Acknowledgment is made of the receipt and entry of the amendment filed on 12/01/2025, wherein claims 1-8 are amended.
Election/Restrictions
Applicant elected without traverse of Group I, pharmaceutical composition claims 1-8, and autism as the neurodegenerative disease species, in the reply filed 09/04/2025.
Claims 1-8 read on the elected invention and species.
Claims 9-16 and 19-22 are withdrawn from further consideration as being directed to non-elected inventions, there being no allowable generic or linking claim.
Status of Claims
Claims 1-16 and 19-22 are pending in the instant application.
Claims 9-16 and 19-22 remain withdrawn.
Claims 1-8 are currently under examination in this office action.
Response to Arguments
Applicant's remarks filed 12/01/2025 have been fully considered. Any objection and rejection found in the previous Office Action and not repeated herein has been withdrawn in view of amendment and Applicant’s remarks .The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 1 is amended to recite a pharmaceutical composition for treating neurodegenerative brain diseases or inflammatory brain diseases comprising N-palmitoyl serinol as an effective component and glyceryl stearate and carboxymethyl cellulose (CMC) as excipients. The excipient glyceryl stearate and carboxymethyl cellulose (CMC) add additional elements that are sufficient to amount to significantly more than the judicial exception. Thus, the 35 U.S.C. 101 rejection is withdrawn.
In response to amendment, claims 1-3 rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Lee et al. (KR101983566B1) are withdrawn. Claims 1-6 rejected under 35 U.S.C. 102 (a)(1) and (a) (2) as being anticipated by Bieberich et al. (US 6,410,597 B1, “Bieberich’ 597”) are withdrawn.
As necessitated by amendment, claims 1-8 are now rejected by Bieberich’ 597 in view of Lee et al. (KR101983566B1/ US20200276096A1), Della Valle et al. ( US 20150265568A1) and Antonucci. Lee’566 collectively teaches pharmaceutical composition comprising palmitoyl serinol in combination with glyceryl stearate and cellulose as excipient. Della Valle teaches pharmaceutical composition comprising palmitoylethanolamide and carboxymethyl cellulose. A skilled artisan would have known glyceryl stearate and carboxymethyl cellulose (CMC) are commonly used pharmaceutical acceptable excipients as taught by Lee’566 and Della Valle. Glyceryl stearate is commonly used as nonionic emulsifiers, stabilizers, emollients, and plasticizers in a variety of food, pharmaceutical, and cosmetic applications. Carboxymethyl cellulose CMC is a well-known pharmaceutical excipient as binder, suspending agent, gelling agent in pharmaceutical industry. Exploring different excipient for pharmaceutical composition is within the knowledge of a person of ordinary skilled in the art. Instant specification does not demonstrate the particular combination of glyceryl stearate and carboxymethyl cellulose produce any unexpected property beyond their role as excipient.
Applicant’s argument about unexpected result is fully considered, but NOT persuasive. It’s noted instant claims are directed to pharmaceutical composition wherein the intended use of treating vast variety of neurodegenerative disease does not necessarily contribute to the structural limitation of composition. Please note “increasing the amount of acetylcholine and decreasing the amount of inflammatory cytokine to protect brain cells, and thus, an effect of improving cognitive ability and memory” is the property of N-palmitoyl serinol / Neuromide. Bieberich’ 597 already teaches N-palmitoyl serinol / Neuromide composition for treating disease conditions associated with neuroinflammatory, e.g. Alzheimer’s disease. MPEP 2112.I. states: "[T]he 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).
Priority
This application 18/024,967 filed on 03/06/2023 is 371 of PCT/IB2021/058477 filed 09/17/2021, which claims priority to Koran Patent Application Nos. KR 10-2020- 0121453, filed on September 21, 2020, and KR 10-2021-0123961, filed on September 16, 2021.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of foreign Application Nos. KR 10-2020- 0121453 and KR 10-2021-0123961 are filed on 03/06/2023 in Korean, no English translation is included in the certified copy of foreign Application Nos KR 10-2020- 0121453 and KR 10-2021-0123961. Applicant’s right of foreign priority is not perfected due to lack of English translation thereof. Applicant is advised to provide certified English translation copy of foreign Application Nos KR 10-2020- 0121453 and KR 10-2021-0123961 to perfect the priority benefit. The prior art earlier than September 21, 2020 is searched.
Claim Interpretation
Instant claims are directed to pharmaceutical composition comprising N-palmitoyl serinol as an effective component for treating neurodegenerative brain diseases or inflammatory brain diseases.
According to PubChem database (CID# 986230, created on 10/25/2006, retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/Palmitoyl-Serinol), N-palmitoyl serinol is also known as Neuromide, N-palmitoyl-2-amino-1,3-propanediol, etc.
Instant claims are product claims. The amended limitation “ treating neurodegenerative brain diseases or inflammatory brain diseases ” are constructed as intended use/function of N-palmitoyl serinol which do NOT necessarily contribute to the structural limitation of pharmaceutical compositions. The biological/ pharmacological activity is the property of N-palmitoyl serinol and a chemical composition and its properties are inseparable. In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. MPEP 2112.I. states: "[T]he 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). If the prior art structure is capable of performing the intended use/function, then it meets the limitation.
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.
Claims 2 and 3 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 and 3 depend on claim 1 and further directed to intended use of N-palmitoyl serinol composition for treating variety of neurodegenerative brain diseases or inflammatory brain diseases. Please note instant claims are directed to composition wherein intended use/function of N-palmitoyl serinol do NOT necessarily contribute to the structural limitation of pharmaceutical compositions. As such, claims 2 and 3 fail to further limit the pharmaceutical composition of claim 1.
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.
Claim Rejections - 35 USC§ 103
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 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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Bieberich et al. (US 6,410,597 B1, “Bieberich’ 597”) , in view of Lee et al. (KR101983566B1, “Lee’566”, published on 05/29/2019, Applicant’s IDS dated 03/06/2023, patent family of US 20200276096A1/US 10987293 B2/ WO 2019172572A1), Della Valle et al. ( US 20150265568A1), and Antonucci et al.( Hindawi Publishing Corporation Case Reports in Psychiatry, Volume 2015, Article ID 325061, 6 pages, http://dx.doi.org/10.1155/2015/325061,
Beneficial Effects of Palmitoylethanolamide on Expressive Language, Cognition, and Behaviors in Autism)( (partially newly reapplied as necessitated by amendment).
Bieberich’ 597 disclosed ceramide analogs, Formula II (e.g. N-palmitoyl serinol /S16) and method for treating disease conditions associated with abnormal cellular proliferation, inflammation, neurodegenerative (e.g. Alzheimer’s disease) or any disease/disorder associated with aberrant protein kinase PKCς in a patient in need thereof, comprising administering a sufficient amount of ceramic analogs (e.g. N-palmitoyl serinol /S16) (See abstract, Fig. 1B; Col. 3, lines 21-34; Col. 4, line 35- 52; claims 1-4). Bieberich’ 597 explicitly disclosed N-palmitoyl serinol /S16 (2-palmitoyl-1,3-propanediol) (See Fig 1-8, Col. 6, lines 34-35’ Examples 1-8, claim 4).
Regarding the administration limitation, Bieberich’ 597 teaches ceramide compounds could be formulated in a wide variety of pharmaceutical forms with pharmaceutical acceptable carriers/excipients and administered orally, intravenously, intraperitoneally, intratumorally, etc. or any therapeutically acceptable method of administration (See Col. 5, lines 50-59; Col. 8, lines 9-10). Bieberich’ 597 teaches intraperitoneal administration of N-palmitoyl serinol /S16 solution composition comprising other inactive ingredients (e.g. sodium stearate, sodium chloride ) (See Col.8, lines 19-26).
Bieberich’ 597 collectively teaches clinical benefit of ceramide analogs ( e.g. N-palmitoyl serinol /S16) for treating disease/disorder associated with aberrant protein kinase PKCς (e.g. neurodegeneration, Alzheimer’s disease, inflammation, etc. ), and other advantages over ceramide, e.g. high aqueous solubility, no or low toxicity in in-vivo animal models, low-cost manufacturing, etc. (See Col. 13, lines 21-35).
Bieberich’ 597 is silent about composition comprising glyceryl stearate and carboxymethyl cellulose (CMC) as the inactive ingredient.
The teachings of Lee’566 (KR101983566B1) in Korean is elaborated as in its patent family Lee’096 (US20200276096A1).
Lee’096/ Lee’566 teach composition comprising serinol- based compound (e.g. palmitoyl serinol) fatty acid, fatty acid alcohol, and pharmaceutical carrier (e.g. methyl cellulose, etc.) for treating or improving a mental disorder (e.g. attention deficit hyperactivity disorder, intermittent explosive disorder, depression, or conduct disorder, etc. )(See abstract, [0024], [0027], [0076]-[0081], Examples 1-6, claims 1-3, 5-13). The mental disorder (e.g. depression, ADHD, etc. ) read on instant claimed neurodegenerative or neuroinflammatory disease. Lee’572/ Lee’096 teach cannabinoid type 1 receptor agonists (e.g. palmitoyl ethanolamide PEA) improves autism symptoms in autistic patients which provide rational of cannabinoid type 1 receptor agonist for treating or improving mental disorders (e.g. autism, hyperactivity disorder) (See [0005]).
Regarding the amended limitation of excipient, Lee’096/ Lee’566 teaches variety of pharmaceutical carrier(e.g. cellulose, methyl cellulose) (See [0083]) and explicitly teaches glyceryl stearate as excipient in combination with palmitoyl serinol (See [0115], Table 1). Please note the cellulose/methylcellulose carrier is construed as read on instant recited carboxymethyl cellulose (CMC).
Della Valle et al. teaches pharmaceutical composition comprising
palmitoylethanolamide (PEA) and pharmaceutical excipient for controlling inflammatory and/or neuropathic pain (See abstract, [0001], Examples A-G, claims 11-29). Della Valle teaches pharmaceutical compositions comprising variety of excipient ( e.g. cellulose derivatives, See [0035]), in variety of form(e.g. tablet, etc.) for different administration route (e.g. orally, parenteral, etc. ) (See [0034]- [0039]). Della Valle explicitly teaches palmitoylethanolamide (PEA) administered in 2% carboxymethyl cellulose(See [0043]).
Bieberich’ 597 is silent about health function food as recited in claims 7 and 8. However, based on the beneficial teachings of Bieberich’ 597, it would be prima facie obvious to explore the non-toxic ceramide analogs ( e.g. N-palmitoyl serinol /S16) in other dosage form for suitable use, including as food supplement.
Bieberich’ 597 is silent about autism. As noted in Claim Interpretation section, the limitation “treating neurodegenerative brain diseases or inflammatory brain diseases” is construed as intended function of composition comprising N-palmitoyl serinol, which doesn’t necessarily contribute to the structural limitation of composition comprising N-palmitoyl serinol. MPEP 2112.01 Il states: "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. MPEP 2112.I. states: "[T]he 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).
Antonucci teaches beneficial effects of palmitoylethanolamide PEA on expressive language, cognition, and behaviors in autism, wherein palmitoylethanolamide PEA was administered orally as food supplementation (See page 1, Introduction; Case presentations on page 2-3; Table 1, Figure 1). Antonucci teaches palmitoylethanolamide (PEA) is nonprescription medical food supplement to human subjects in Europe since 2008 without any noted significant side effects (See Introduction). Antonucci teaches the link between autism spectrum disorders (ASDs) and inflammatory state (See Introduction), and potential mechanism of palmitoylethanolamide on autism, associated with anti-inflammatory effect of palmitoylethanolamide on chronic brain inflammatory disorder including autism (See page 2, left column; Discussion on page 4). Antonucci also teaches other anti-inflammatory agents might have beneficial effect on autism (See Discussion on page 3-4; Conclusion).
It would have been prima facie obvious to a person of ordinary skilled in the art to modify pharmaceutical composition comprising N-palmitoyl serinol taught by Bieberich’ 597 and Lee’096/ Lee’566 with the teachings of pharmaceutical composition comprising palmitoylethanolamide taught by Della Valle and further explore N-palmitoyl serinol for treating neurodegenerative/ neuroinflammatory disease (e.g. autism) as taught by Antonucci, and arrive at instantly claimed invention with reasonable expectation of success. Lee’096/ Lee’566 collectively teaches pharmaceutical composition comprising palmitoyl serinol in combination with glyceryl stearate and methyl cellulose as excipient. Della Valle teaches pharmaceutical composition comprising palmitoylethanolamide and carboxymethyl cellulose. A skilled artisan would be motivated to combine teachings of Bieberich’ 597, Lee’096/ Lee’566, Della Valle and Antonucci based on their beneficial teachings because all are directed to N-palmitoylamide in the treatment of neurodegeneration/ neuroinflammatory disease. Both N-palmitoyl serinol and palmitoylethanolamide are hydroxyalkyl N-palmitoylamide that have very similar chemical structures and anti-inflammatory effect on chronic brain inflammation. The combined teachings of prior art , together with exploration/optimization based on general knowledge of pharmaceutical composition/ food supplement for treating neuroinflammatory disease would provide pharmaceutic composition comprising N-palmitoyl serinol that can be used as food supplement and benefit subjects having neuroinflammatory disease (e.g. autism disorder).
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art, together with exploration/optimization based on general knowledge of pharmaceutical composition/ food supplement for treating neuroinflammatory disease. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, and 8-10 of U.S. Patent No. 10987293 B2 in view of Lee et al. (KR101983566B1, “Lee’566”, published on 05/29/2019, Applicant’s IDS dated 03/06/2023, patent family of US 20200276096A1/WO 2019172572A1) (partially newly reapplied as necessitated by amendment).
Reference claims are directed to composition for skin external application comprising a serinol-based compound selected from the group consisting of palmitoyl serinol and valproyl serinol, a sterol-based compound, a higher fatty acid, and a higher fatty acid alcohol. Reference claims 8-10 recite the pharmaceutical composition for treating or improving a mental disorder, e.g. attention deficit hyperactivity disorder, intermittent explosive disorder, depression, or conduct disorder.
Reference claims are silent about glyceryl stearate and carboxymethyl cellulose (CMC) as the inactive ingredient. A skilled artisan would have known glyceryl stearate and carboxymethyl cellulose (CMC) are commonly used pharmaceutical acceptable excipients.
As elaborated in preceding 103 rejection, Lee’096/ Lee’566 collectively teaches pharmaceutical composition comprising palmitoyl serinol in combination with glyceryl stearate and methyl cellulose as excipient. Lee’096/ Lee’566 also teaches cannabinoid type 1 receptor agonists (e.g. palmitoyl ethanolamide PEA) improves autism symptoms in autistic patients which provide rational of cannabinoid type 1 receptor agonist for treating or improving mental disorders (e.g. autism, hyperactivity disorder) (See [0005]).
As stated in Claim Interpretation section, the limitation “ for improving cognitive ability or enhancing memory ” are constructed as intended use/function of N-palmitoyl serinol which do NOT necessarily contribute to the structural limitation of pharmaceutical compositions. Further, autism and attention-deficit/hyperactivity disorder (ADHD) commonly co-occur with each other and with other mental disorders, e.g. conduct disorder (ODD/CD). Administering palmitoyl serinol would also be improving autism in subjects suffering both ADHD and autism. It would also be prima facie obvious for an ordinary skilled in the art to further explore palmitoyl serinol for treating/or improving autism in subjects in need thereof.
Reference claims are silent about instant claimed formulation for oral or parenteral administering or food . However, oral formulation (e.g. tablet, liquid, syrup, etc.) and parenteral formulation in aqueous or oily solvent are commonly used dosage form and a skilled would have known to explore palmitoyl serinol in other dosage form for suitable use, including as food supplement.
The instant application shares at least one common inventor/applicant with the reference patent. Based on the continuing data on the record, instant application is not related to the reference patent, thus no 35 USC 121 shield exists.
Conclusion
No claims are allowed
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cohen et al. US 20200113950 A1 (Cohen teaches composition comprising N-Acyl amide derivative (e.g. N-palmitoyl serinol, etc.) and method of modulation of G protein-coupled receptors ( GPCRs) for treating human disease. Cohen teaches pharmaceutical carriers, e.g. carboxymethylcellulose, etc.)
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 LIYUAN MOU whose telephone number is (571)270-1791. The examiner can normally be reached Mon-Fri 9:00-5:30.
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/LIYUAN MOU/ Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628