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 .
Election/Restriction
Applicant's election without traverse of Invention group II, claims 24-27 drawn to a method of producing a mammalian milk like product, in the reply filed on 07/13/2026 is acknowledged.
Claims 1-3, 5, 9, 12, 14, 16, 19-22 and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/13/2026.
Claim status
Claims 1-3, 5, 9, 10, 12, 14, 16, 19-22,24-27 and 29 are pending.
Claims 1-3, 5, 9, 12, 14, 16, 19-22 and 29 are withdrawn.
Claims 4, 6-8, 11, 13, 15, 17-18, 23, 28, 30-37 are cancelled.
Claims 24-27 are under examination.
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.
Regarding claim 24, (i) claim lacks prior definition of step A and B; therefore, there is insufficient antecedent basis which renders the claim unclear.
(ii) step D as whole is referring to step A and culturing hBSCs is not previously recited or implicit to steps C or D. Hence the claim lacks antecedent basis and therefore unclear. Therefore, the claim fails to clearly and distinctly recite the subject matter. Hence, the claim is indefinite.
Regarding claim 26, the claim is referring to a step A in claim 24, wherein claim 24 does not recite a step A. Therefore, the claim fail to clearly and distinctly recite the subject matter. Hence, the claim is indefinite.
Regarding claim 27, (i) the claim is referring to a step A in claim 24, wherein claim 24 does not recite a step A, hence the claimed subject matter is not clear.
(ii) the claim recites indefinite language, the phrase "for example", it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
(iii) the claim contains the trademark/trade name MammoCult. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe culture media and, accordingly, the identification/description is indefinite.
Therefore, the claim fail to clearly and distinctly recite the subject matter. Hence, the claim is indefinite.
Claim interpretation
The claim 24 is missing the steps A and B. The only clear limitations to the claim are step C and D with an end result of secreting a milk-like product. Therefore if a prior art discloses steps C and D and secretion of a milk-like product, the art is applicable to reject the claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 24, 25, 26,27 are rejected under 35 U.S.C. 102(a1) as being anticipated by Hassiotou, et al. Stem cells 30.10 (2012): 2164-2174.
Regarding claim 24, Hassiotou teaches a method of producing a milk- like product (Differentiation of breastmilk stem cells into cells originating from the three germ layers, page 2170, fig.4 B western blot analysis of secreted milk proteins).
Regarding claim 24C, Hassiotou teaches generating 3D spheroids or mammospheres, derived from human (i.e., mammalian) breast milk stem cells (hBSC) (Differentiation of breastmilk stem cells into cells originating from the three germ layers, page 2170, figs 3).
Regarding claim 24D, Hassiotou teaches the secretion of α-lactalbumin, lactoferrin and β-casein specific to lactocytes from the mammospheres derived from hBSC (paragraph 2, page 2172). Fig 4A also illustrate a β-casein expressing ‘lactocyte’ in mammospheres derived from hBSC.
Claim 24, does not recite a step A), therefore the steps recited after the wherein clause is not clear (see 112 b rejection).
Regarding claim 25, this clam further limits the method of claim 24 step A which is not recited thus not required by the claim. Therefore, Hassoitou meets the limitations of the claim.
Regarding claim 26, claim 24 does not recite a step A) therefore the steps recited after the wherein clause is not clear (see 112 b rejection). Hassoitou meets the limitations of the claim.
Regarding claim 27, Hassiotou teaches producing a human milk-like product (Differentiation of breastmilk stem cells into cells originating from the three germ layers, page 2170, fig.4 B western blot analysis of secreted milk proteins).Further, the claim 24 do not recite a step A), therefore the steps recited after the wherein clause is not clear (see 112 b rejection). Therefore, the reference teach the limitations in claim 27.
Therefore the reference anticipates the claimed invention
Conclusion
No claims allowed.
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/HASHANTHI KOMITIGE ABEYRATNE-PERERA/ Examiner, Art Unit 1632 /MARCIA S NOBLE/Primary Examiner, Art Unit 1632
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