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.
Election/Restrictions
Applicant’s election of species without traverse in the reply filed on 2/26/2026 is acknowledged.
Applicant elected compliant species of acyl-glycerophospholipid: compound of formula II
PNG
media_image1.png
144
269
media_image1.png
Greyscale
where R1 and R2 are H; R4 is CH3; and n is 2, (alpha-glycerolphosphocholine), the elected species reads on claims 21-25, 27, 30, 33-39, 41 and 44 and 47-48.
Examiner found prior art on applicant elected species therefore Markush search is not extended to other species of acyl glycerophospholipid.
Claims 26, 28-29, 31-32, 40, 42-43 and 45 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species , there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/26/2026.
Current Status of 17/996,370
This Office Action is in response to the amended claims of 06/13/2023.
Claims 21-48 are new.
Claims 26, 28-29, 31-32, 40, 42-43 and 45 are withdrawn.
Claims 21-25, 27, 30, 33-39, 41 and 44 and 47-48 are examined in this office action.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 10/17/2022. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Priority
Effected filing date is 04/17/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112
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 22-25, 27, 30, 33-34 and 39 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 22,25 and 39 recites the phrase “including” within the claims. There are at least 2 occurrence of the phrase “including” in claim 22 and once in each claims 25 and 39. The examiner does not know if the phrase “including” further limits the embodiments in the claim or list the different embodiments of the claims. Moreover, the reader does not know if the limitations following “including” are merely exemplary or are required limitations of the claim. As drafted, the term “including” renders the metes and bounds of claims 22, 25 and 39 undefined hence rendering claims 22,25 and 39 indefinite. Please delete all occurrences of “including” to render moot this rejection.
Claims 22 and 37 are rejected as indefinite under 35 USC 112(b) since these claims have “especially”. The use of “especially” renders the metes and bounds of claims 22 and 37 undefined (hence rendering claims 22 and 37 indefinite under 35 USC 112(b)). The artisan does not know whether the limitations following “especially” are merely exemplary or are required limitations of the claim.
Claims 27 is also rejected as indefinite because they refer back to claims 25 but do not remedy the bases for the rejection of claims 25.
In claim 22, there is numerous occurrences of the term “such as” is not defined by the claims. The limitation “such as” of claim 22 render the metes and bounds of the claim undefined, since the artisan is uncertain whether the limitations following “such as are merely exemplary or are required limitations of the claims. As drafted “such as” in claim 22 renders the metes and bounds of claims 22 indefinite.
Please remove “such as” from claim 22 to render moot this rejection.
Claim 22 contains at least two occurrence of parentheticals. See the circled area below
PNG
media_image2.png
494
1179
media_image2.png
Greyscale
. Claims are not allowed to have limitations within parentheticals since the readers does not know whether the limitation within the parentheticals are merely exemplary or a required limitation of the claims. Only abbreviations are allowed in parentheticals. Thus, parentheticals of claim 22 renders metes and bounds of claim 22 undefined hence rendering claim 22 indefinite.
The term “derivatives thereof” is not defined by claims 21. The specification does not provide definition of the term “derivatives thereof”. One of ordinary skill in the art could not reasonably determine the scope of the term “derivatives thereof”. As drafted “derivatives thereof” in claim 21 renders the metes and bounds of claim 21 indefinite.
Claims 22-25, 27, 30 and 33-34 are also rejected as indefinite because they refer back to claim 21 but do not remedy the bases for the rejection of claim 21.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 21-25, 27, 30 and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over
Arshad et.al (J Transl Med (2019) 17:365)
In view of
Liapi et.al. Ann Res (Hosp 2019, 3:12 http://dx.doi.org/10.21037/arh.2019.05.02.)
In further view of
Iemitsu et.al. (Nutrition 28 (2012) 1122-1126).
In further view of
Anisel et.al. “PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS” 7th edition, 1999.
1. Determining the scope and contents of the prior art.
Claims are directed to method of treatment or aftercare of inflammatory diseases, such as pneumonia, in humans by administering alpha-gycerolphosphocholine (alpha-GPC) (claims 21-25, 27, 30 and 33-34)
Arshad et.al. teaches the levels of lysophosphatidylcholines are greatly reduced in patient with pneumonia and return to normal with clinical improvement(abstract).
Liapi et.al teaches in Figure 2
PNG
media_image3.png
327
564
media_image3.png
Greyscale
Schematic representation of the effect of choline or choline deficiency on various inflammatory and non-inflammatory mediators in sepsis: part A reflects choline’s role in inhibiting endotoxin-induced sepsis; part B reflects the potential role of choline-deficiency in intensifying endotoxin-induced sepsis. ALP, alkaline phosphatase; ALT, alanine aminotransaminase; BOOH-CL, tert-butyl hydroperoxide initiated chemiluminescence; CK, creatine kinase; EGF, epidermal growth factor; Hcy, homocyteine; LDH, lactate dehydrogenase; GSH, glutathione; PGE2, prostaglandin E2; TBRAS, thiobarbituric acid reactive substances; TRAP, total radical-trapping antioxidant parameter; IL-1, interleukin 1; IL-6; interleukin 6; IL-10, interleukin 10; INF-γ, interferon gamma; MMPs, matrix metalloproteinases; NO, nitric oxide; TNF-α, tumor necrosis factor alpha; (↑), increase; (↓), decrease. Figure 2 Schematic representation of the effect of choline or choline deficiency on various inflammatory and non-inflammatory mediators in sepsis: part A reflects choline’s role in inhibiting endotoxin-induced sepsis; part B reflects the potential role of choline-deficiency in intensifying endotoxin-induced sepsis. ALP, alkaline phosphatase; ALT, alanine aminotransaminase; BOOH-CL, tert-butyl hydroperoxide initiated chemiluminescence; CK, creatine kinase; EGF, epidermal growth factor; Hcy, homocyteine; LDH, lactate dehydrogenase; GSH, glutathione; PGE2, prostaglandin E2; TBRAS, thiobarbituric acid reactive substances; TRAP, total radical-trapping antioxidant parameter; IL-1, interleukin 1; IL-6; interleukin 6; IL-10, interleukin 10; INF-γ, interferon gamma; MMPs, matrix metalloproteinases; NO, nitric oxide; TNF-α, tumor necrosis factor alpha; (↑), increase; (↓), decrease.proinflammatory cytokines (page 7, figure 2).
Iemitsu et. al teaches oral administration of alpha-GPC (examiner interpret this direct ingestion (claim 33-34) is absorbed in the intestine and plasma and with high circulating levels of choline(page 1122, introduction) partially teaching claims 21-25, 27 and 30.
Anisel et.al. teaches dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50)
2. Ascertaining the differences between the prior art and the claims at issue.
Arshad et.al. teaches the levels of lysophosphatidylcholines are greatly reduced in patient with pneumonia and return to normal with clinical improvement. Arshad does not teach the method of treatment or aftercare of inflammatory diseases with alpha-GPC.
Liapi et.al teaches choline deficiency on various inflammatory and non-inflammatory mediators in sepsis. Increasing choline helps in promoting lowering inflammatory cytokines and increases anti-inflammatory cytokines. Liapi et.al. does not teach the method of treatment or aftercare of inflammatory diseases with alpha-GPC.
Iemitsu et. al teaches oral administration of GPC (examiner interpret this as alpha-GPC (claim 33) is absorbed in the intestine and plasma and with high circulating levels of choline. Iemitsu et.al. does not teach the method of treatment or aftercare of inflammatory diseases with alpha-GPC(page 1122, introduction).
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skilled is an artisan who is trying increase choline level in human body with supplements for treating inflammatory diseases.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to treat inflammatory diseases with alpha-GPC in patients with pneumonia with low level of lysophosphatidylcholines, (Arshard, abstract). because alpha-GPC increases choline in plasma (page 1122, introduction) which is known to help in generating anti-inflammatory cytokines and lower inflammatory cytokines and prevent sepesi (Liapi et.al page 7, figure 2). Therefore, it would be expected administering alpha-GPC will be able to treat inflammatory diseases because alpha-GPC is expected to increase the amount of choline in plasma which in turn can help in reducing anti-inflammatory cytokines and prevent sepsis. Therefore, it would be prima facia obvious to combine the teaching of Arshad et.al with combined teaching of Liapi et.al and Iemitsu et. al to teach all the elements of claims 21-25, 27, 30 and 33-34.
Claims 27 and 33 are directed to dosage and concentration of alpha-GPC. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50). Generally, dosage and concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. The specification does not indicate the dosage and frequency of the dosage to be critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Claim(s) 35-39, 41 44 and 47-48 are rejected under 35 U.S.C. 103 as being unpatentable over
Singh et. al. (Inflammation and cancer. Ann Afr Med 2019;18:121-6).
In view of
Liapi et.al. Ann Res (Hosp 2019, 3:12 http://dx.doi.org/10.21037/arh.2019.05.02.)
In further view of
Iemitsu et.al. (Nutrition 28 (2012) 1122-1126).
In further view of
Anisel et.al. (PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS) 7th edition, 1999.
1. Determining the scope and contents of the prior art.
Claims are directed to method of treatment of convalescence after cancer or cancer treatment in humans by administering alpha-gycerolphosphocholine (alpha-GPC) (claims 35-39, 41 44 and 47-48)
Singh et.al teaches inflammation is associate with cancer and are often targeted for both treating and preventing cancer(abstract). Pro-inflammatory cytokines, chemokines, adhesion molecules, and inflammatory enzymes has been linked with chronic inflammation(page 122). Chronic inflammation has been linked to various steps involved in tumorigenesis, including cellular transformation, promotion, survival, proliferation, invasion, angiogenesis, and metastasis (page 123) (partially teaching claims 35-36)
Liapi et.al teaches in Figure 2
PNG
media_image3.png
327
564
media_image3.png
Greyscale
Schematic representation of the effect of choline or choline deficiency on various inflammatory and non-inflammatory mediators in sepsis: part A reflects choline’s role in inhibiting endotoxin-induced sepsis; part B reflects the potential role of choline-deficiency in intensifying endotoxin-induced sepsis. ALP, alkaline phosphatase; ALT, alanine aminotransaminase; BOOH-CL, tert-butyl hydroperoxide initiated chemiluminescence; CK, creatine kinase; EGF, epidermal growth factor; Hcy, homocyteine; LDH, lactate dehydrogenase; GSH, glutathione; PGE2, prostaglandin E2; TBRAS, thiobarbituric acid reactive substances; TRAP, total radical-trapping antioxidant parameter; IL-1, interleukin 1; IL-6; interleukin 6; IL-10, interleukin 10; INF-γ, interferon gamma; MMPs, matrix metalloproteinases; NO, nitric oxide; TNF-α, tumor necrosis factor alpha; (↑), increase; (↓), decrease. Figure 2 Schematic representation of the effect of choline or choline deficiency on various inflammatory and non-inflammatory mediators in sepsis: part A reflects choline’s role in inhibiting endotoxin-induced sepsis; part B reflects the potential role of choline-deficiency in intensifying endotoxin-induced sepsis. ALP, alkaline phosphatase; ALT, alanine aminotransaminase; BOOH-CL, tert-butyl hydroperoxide initiated chemiluminescence; CK, creatine kinase; EGF, epidermal growth factor; Hcy, homocyteine; LDH, lactate dehydrogenase; GSH, glutathione; PGE2, prostaglandin E2; TBRAS, thiobarbituric acid reactive substances; TRAP, total radical-trapping antioxidant parameter; IL-1, interleukin 1; IL-6; interleukin 6; IL-10, interleukin 10; INF-γ, interferon gamma; MMPs, matrix metalloproteinases; NO, nitric oxide; TNF-α, tumor necrosis factor alpha; (↑), increase; (↓), decrease.proinflammatory cytokines (page 7, figure 2).
Iemitsu et. al teaches oral administration of alpha-GPC (examiner interpret this direct ingestion (claim 35-36) is absorbed in the intestine and plasma and with high circulating levels of choline (page 1122, introduction) partially teaching claims 35-36, 41 44 and 47-48.
Anisel et.al. teaches dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50)
2. Ascertaining the differences between the prior art and the claims at issue.
Singh et.al teaches chronic inflammation has been linked to various steps involved in tumorigenesis, including cellular transformation, promotion, survival, proliferation, invasion, angiogenesis, and metastasis. Singh et.al. does not teach the method of treatment or aftercare of cancer with alpha-GPC.
Liapi et.al teaches choline deficiency on various inflammatory and non-inflammatory mediators in sepsis. Increasing choline helps in promoting lowering inflammatory cytokines and increases anti-inflammatory cytokines. Liapi et.al. does not teach the method of treatment or aftercare of cancer with alpha-GPC.
Iemitsu et. al teaches oral administration of GPC (examiner interpret this as alpha-GPC is absorbed in the intestine and plasma and with high circulating levels of choline. Iemitsu et.al. does not teach the method of treatment or aftercare of inflammatory diseases with alpha-GPC(page 1122, introduction).
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skilled is an artisan who is trying increase treat cancer level in human body with supplements for treating inflammatory diseases.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to treat cancer with alpha-GPC in patients with cancer which causes chronic inflammation (Singh et.al. abstract page 122-123 ) because alpha-GPC increases choline in plasma (page 1122, introduction) which is known to help in generating anti-inflammatory cytokines and lower inflammatory cytokines and prevent sepsis(examiner interpret this as convulsion) (Liapi et.al page 7, figure 2). Therefore, it would be expected administering alpha-GPC will be able to treat chronic inflammation caused cancer because alpha-GPC is expected to increase the amount of choline in plasma which in turn can help in reducing anti-inflammatory cytokines and prevent sepsis in patients with cancer. Therefore, it would be prima facia obvious to combine the teaching of Singh et.al with combined teaching of Liapi et.al and Iemitsu et. al to teach all the elements of claims 35-39, 41 44 and 47-48.
Claims 41 and 47 are directed to dosage and concentration of alpha-GPC. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50). Generally, dosage and concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. The specification does not indicate the dosage and frequency of the dosage to be critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Conclusion
No claims are allowable as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rehana Ismail whose telephone number is (703)756-4776. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew D Kosar can be reached at (571)272-913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
Prosecution Insights