Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
New claims 48-62 are pending in the application. Claims 1-47 have been canceled. (Preliminary amendment filed 12 April 2023.
Priority
This application is a continuation of 16/941,225 filed 07/28/2020, now abandoned, which is a continuation of 12/682,582 filed 09/21/2010, now abandoned, which is a 371 of PCT/NZ2008/000274 filed 10/20/2008. This application claims foreign priority to NZ 562706 filed 10/19/2007 and to NZ 562708 filed 10/19/2007, under 35 U.S.C. 119(a)-(d). The certified copy of the priority document has been filed in parent application 12/682,582.
The foreign priority documents NZ 562706 and NZ 562708 do not provide support for administration of the composition wherein one or more complex lipids comprise more phosphatidylethanolamine than phosphatidylcholine by weight and/or more phosphatidylethanolamine than sphingomyelin by weight. In Tables 2a and 2b of the specification of PCT application PCT/NZ2008/000274, filed 10/20/2008, fractions 1-11 comprise more PE than PC and more PE than SM. The priority date accorded is 10/20/2008.
Drawings
The drawings are objected to because in Figure 4 filed 12/20/2022, on the X-axis, the term ‘Does’ should be ‘Dose’. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 48-62 are rejected under 35 U.S.C. 103(a) as being unpatentable over Shulman et al (WO 2006/114790 A2; cited in IDS filed 02/28/2023) in view of Fletcher et al (WO 2006/041316 A1; cited in IDS filed 02/28/2023).
Shulman et al teaches compositions comprising phospholipids and sphingomyelins from milk for infants and young children and pregnant women (page 10, last paragraph). The composition can contain a wide percentage range of all the polar lipids, namely phosphatidyl choline, phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol, sphingomyelins (page 12, paragraphs 1-3; pages 23-26, first paragraph; part of limitations of claims 48-49 and 59-60). The components are known to play a very important role in the nutrition of developing infants and are useful for enhancement of infants and/or children development (page 1, paragraph 4; page 16, third full paragraph). The phospholipids are also for pregnant women (page 5, second paragraph; page 42, third paragraph; as in claim 59).
According to Shulman, its composition is intended for use in the enhancement of brain development since phosphatidylserine is an important building block for brain tissues, and phospholipids are important for brain development (page 42, last para). The consumption of the composition is also intended for enhancement of physical development. Additionally, food products containing phospholipids also assist in the absorption and bio-availability of a variety of supplemental nutrients, especially calcium. A significant part of human brain development happens in utero (page 44, paras three through five). This teaching of Shulman is a suggestion to administer a composition comprising one or more complex lipids in a method of increasing growth of a foetal subject wherein growth is brain weight as in claims 48, 59 and 60 since phospholipids are the building blocks of brain tissues. Building blocks of brain tissues indicates brain weight as in claims 48, 59 and 60. The teaching that phospholipids also assist in the absorption and bio-availability of a variety of supplemental nutrients, especially calcium indicates that growth is bone mineral density as in claim 61.
Shulman’s composition is useful for enhancement of infants and/or children’s physical development. This is a suggestion that the composition of Shulman when administered will maintain or increase body weight, body length and height as in claims 61 and 62. Since Shulman’s composition is also for administering to pregnant women it would be obvious to the artisan to provide it to a pregnant mother and informing the mother that the composition will maintain or increase growth of the foetal subject as in claim 59.
Shulman does not expressly teach administering a composition wherein the complex lipids comprise more phosphatidylethanolamine than phosphatidylcholine by weight and/or more phosphatidylethanolamine than sphingomyelin as in claim 48, 59 and 60, and does not teach the limitations of claims 50-58.
Fletcher et al teaches compositions comprising complex lipids which are phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol, phosphatidylserine and including at least 0.1% w/w gangliosides GM3 and GD3, sphingomyelin (page 24, Table 6; part of the limitations of claims 48-51). The composition can also contain sphingolipids (page 5, fourth full paragraph; part of the limitations of claim 49). The ingredients are obtained from milk fat globule via extraction (page 9, second paragraph; page 13, paragraph four; page 14, first full paragraph; limitation of claim 54). Composition D of Fletcher et al, disclosed in Table 6 at page 24, has 22% w/w of phosphatidylethanolamine, 13.3% phosphatidylcholine and 15.1% sphingomyelin. The composition has more phosphatidylethanolamine by weight than phosphatidylcholine and sphingomyelin as in claims 48, 59 and 60. The compositions of Fletcher et al is for infants and children and the composition produces several health benefits (page 9, paragraphs 4 and 5; page 13, paragraph 2; part of the limitations of claim 60). Fletcher discloses in the background section that increasing the levels of phospholipids and glycosphingolipid leads to optimal neural development in addition to others and therefore it is desirable to produce infant formula containing sufficient desirable lipids (page 1, last paragraph through page 2, line 8). This is a suggestion to the artisan to adjust the amounts of phospholipids including the level of phosphatidylethanolamine as in claim 55.
Based on the teachings of the prior art, especially Fletcher, it would be obvious to one of ordinary skill in the art to make different compositions having the amounts/percentages recited in claims 52-53, and 55-58, since a wide percentage range of the ingredients is taught in the prior art (Shulman et al), and one of ordinary skill in the art can also include the ingredients in terms of weight in milligrams/grams as in claims 52-53 and 56-58. Based on the teachings of the prior art it would be obvious to the artisan that the administration of the instant composition would maintain or increase the growth of the subjects as recited in claims 48, 59 and 60.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to make the claimed compositions and use them in the claimed methods since the ingredients recited in the instant claims are taught in the prior art to be useful for increasing, maintaining the growth of fetal subject, infants and children and also provide several other health benefits.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, the ingredients in the composition administered are known to maintain/improve growth of a foetal subject. Thus, it is obvious to combine prior art elements and arrive at the instant method with a reasonable expectation of success.
Fletcher teaches a composition comprising the claimed components including one wherein phosphatidylethanolamine is more than phosphatidylcholine and sphingomyelin. Shulman et al teaches compositions comprising phospholipids, sphingomyelins from milk for infants and young children and pregnant women. The composition can contain a wide percentage range of all the polar lipids, namely phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine, phosphatidylinositol, sphingomyelins. The components are known to play a very important role in the nutrition of developing infants and is useful for enhancement of infants and/or children development, including brain tissues. Even though Shulman’s embodiment is a composition that has more phosphatidylcholine, there is no teaching or suggestion in Shulman that the other phospholipids like phosphatidylethanolamine should not be higher compared to phosphatidylcholine or sphingomyelin. There are no experimental results disclosed which show that higher amounts or percentages of phosphatidylcholine is needed to improve or maintain development or growth. Therefore, one of ordinary skill in the art would be motivated to look at alternate compositions that have more phosphatidylethanolamine than phosphatidylcholine and sphingomyelin and their effects on growth and development as instantly claimed. Suggestion and starting points for adjustments of the amounts is there in the prior art. Thus, the claimed invention as a whole is prima facie obvious over the combined teachings of the prior art.
Conclusion
1. Pending claims 48-62 are rejected.
2. Claims 1-47 have been canceled.
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/GANAPATHY KRISHNAN/ Primary Examiner, Art Unit 1693